Trial · NCT02500979
Effect of a Fixed Pramlintide: Insulin Dose Ratio on Postprandial Glucose in Type 1 Diabetes Mellitus
NCT02500979, Phase 1, Completed, AstraZeneca; results first posted 2018-11-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Effect of a Fixed Pramlintide: Insulin Dose Ratio on Postprandial Glucose in Type 1 Diabetes Mellitus. Trials, record NCT02500979. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02500979
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effect of a Fixed Pramlintide: Insulin Dose Ratio on Postprandial Glucose in Type 1 Diabetes Mellitus
- NCT number
- NCT02500979
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 34 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Type 1 Diabetes Mellitus
- Interventions
- Pramlintide acetate, Placebo, Lispro insulin U-100, Regular insulin U-100
- First posted
- 2015-07-17
- Last updated
- 2018-11-02
- Results first posted
- 2018-11-02
- Limitations and caveats
Due to the unavailability of the pramlintide assay, no data are presented for pramlintide PK parameters, and changes in pramlintide concentration could not be related to changes in insulin, plasma glucose, glucagon, or triglycerides.
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Efficacy of Pramlintide by Measurement of 24-hour Tissue Mean Weighted Glucose (MWG) Obtained With Continuous Glucose Monitoring (CGM) | 24 h | 24-hour MWG mg/dL, defined as total area under the 24-hour tissue glucose curve obtained with CGM, divided by actual time span in the 24-hour period. |
| Secondary | Efficacy of Pramlintide by Measurement of Absolute Plasma Glucose Area Under the Plasma Concentration-time Curve (AUC) Following Lunch | 3 hours | Absolute postprandial plasma glucose AUC was measured for the first 3 hours (AUC0-3h) following lunch based on sample availability. (Sample times: 20 hours \[lunch\], 20 hours 45 min, 21 hours, 23 hours, 24 hours). |
| Secondary | Efficacy of Pramlintide by Measurement of Absolute Plasma Glucose Area Under the Plasma Concentration-time Curve (AUC) Following Dinner | 2 hours | Absolute postprandial plasma glucose AUC (AUC0-2h) was measured for the first 2 hours following dinner based on sample availability. (Sample times: 2 hours \[dinner\], 2 hours 45 min, 3 hours, 4 hours). |
| Secondary | Efficacy of Pramlintide by Measurement of Absolute Plasma Glucose Area Under the Plasma Concentration-time Curve (AUC) Following Breakfast | 2 hours | Absolute postprandial plasma glucose AUC (AUC0-2h) was measured for the first 2 hours following breakfast based on sample availability. (Sample times: 16 hours \[breakfast\], 16 hours 45 min, 17 hours, 18 hours). |
| Secondary | Efficacy of Pramlintide by Measurement of Incremental 24-hour Tissue Glucose Area Under the Plasma Concentration-time Curve (AUC) Obtained With Continuous Glucose Monitoring (CGM) | 24 h | Incremental (i.e., baseline-corrected) area under the 24-hour tissue glucose concentration curve (AUC0-24h) measured by continuous glucose monitoring (CGM) with a pre-test, non-fasting tissue glucose value as baseline. (Sample times: 0, 30 min, 2 hours \[dinner\], 2 hours 45 min, 3 hours, 4 hours, 9 hours, 12 hours, 14 hours, 16 hours \[breakfast\], 16 hours 45 min, 17 hours, 18 hours, 20 hours \[lunch\], 20 hours 45 min, 21 hours, 23 hours, 24 hours). |
| Secondary | Efficacy of Pramlintide by Measurement of Absolute 24-hour Plasma Glucose Area Under the Plasma Concentration-time Curve (AUC) | 24 h | Absolute mean area under the 24-hour plasma glucose concentration curve, measured as total area under the curve (0 to 24 hours). (Sample times: 0, 30 min, 2 hours \[dinner\], 2 hours 45 min, 3 hours, 4 hours, 9 hours, 12 hours, 14 hours, 16 hours \[breakfast\], 16 hours 45 min, 17 hours, 18 hours, 20 hours \[lunch\], 20 hours 45 min, 21 hours, 23 hours, 24 hours). |
| Secondary | Efficacy of Pramlintide by Measurement of Incremental 24-hour Plasma Glucose Area Under the Plasma Concentration-time Curve (AUC) | 24 hours | Incremental (i.e., baseline-corrected) mean area under the 24-hour plasma glucose concentration curve, measured as total area under the curve (0 to 24 hours). (Sample times: 0, 30 min, 2 hours \[dinner\], 2 hours 45 min, 3 hours, 4 hours, 9 hours, 12 hours, 14 hours, 16 hours \[breakfast\], 16 hours 45 min, 17 hours, 18 hours, 20 hours \[lunch\], 20 hours 45 min, 21 hours, 23 hours, 24 hours). |
| Secondary | Efficacy of Pramlintide Measured by Percent Time Spent in the Range of >70 mg/dL to <180 mg/dL Tissue Glucose Obtained With Continuous Glucose Monitoring (CGM) | 24 h | Percent time spent in the normoglycemic range of tissue glucose concentrations between \>70 mg/dL and \<180 mg/dL, measured by CGM. (Sample times: 0, 30 min, 2 hours \[dinner\], 2 hours 45 min, 3 hours, 4 hours, 9 hours, 12 hours, 14 hours, 16 hours \[breakfast\], 16 hours 45 min, 17 hours, 18 hours, 20 hours \[lunch\], 20 hours 45 min, 21 hours, 23 hours, 24 hours). |
| Secondary | Efficacy of Pramlintide by Measurement of Absolute 24-hour Plasma Glucagon Area Under the Plasma Concentration-time Curve (AUC) | 24 h | Absolute mean area under the 24-hour plasma glucagon concentration curve, measured as total area under the curve (total AUC0-24). (Sample times: 0, 30 min, 2 hours \[dinner\], 2 hours 45 min, 3 hours, 4 hours, 9 hours, 12 hours, 14 hours, 16 hours \[breakfast\], 16 hours 45 min, 17 hours, 18 hours, 20 hours \[lunch\], 20 hours 45 min, 21 hours, 23 hours, 24 hours). |
| Secondary | Efficacy of Pramlintide by Measurement of Incremental 24-hour Plasma Glucagon Area Under the Plasma Concentration-time Curve (AUC) | 24 h | Incremental (i.e., baseline-corrected) mean area under the 24-hour plasma glucagon concentration curve with a pre-test, non-fasting plasma glucagon value as baseline. (Sample times: 0, 30 min, 2 hours \[dinner\], 2 hours 45 min, 3 hours, 4 hours, 9 hours, 12 hours, 14 hours, 16 hours \[breakfast\], 16 hours 45 min, 17 hours, 18 hours, 20 hours \[lunch\], 20 hours 45 min, 21 hours, 23 hours, 24 hours). |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Efficacy of Pramlintide by Measurement of 24-hour Tissue Mean Weighted Glucose (MWG) Obtained With Continuous Glucose Monitoring (CGM) | 24 h | Full Analysis Set: Of the 33 correctly randomized subjects, 26 (76.5%) had at least 1 efficacy assessment available from each of the 2 crossover periods and were included in the Full Analysis Set. | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Efficacy of Pramlintide by Measurement of Absolute Plasma Glucose Area Under the Plasma Concentration-time Curve (AUC) Following Lunch | 3 hours | Pharmacokinetic/Pharmacodynamic (PK/PD) Analysis Set: Of the 33 correctly randomized subjects, 26 (76.5%) subjects received at least 1 dose of pramlintide and had evaluable PD data and were, therefore, included in the PK/PD Analysis Set. | mmol/L*h | LEAST_SQUARES_MEAN |
| SECONDARY | Efficacy of Pramlintide by Measurement of Absolute Plasma Glucose Area Under the Plasma Concentration-time Curve (AUC) Following Dinner | 2 hours | Pharmacokinetic/Pharmacodynamic (PK/PD) Analysis Set: Of the 33 correctly randomized subjects, 26 (76.5%) subjects received at least 1 dose of pramlintide and had evaluable PD data and were, therefore, included in the PK/PD Analysis Set. | mmol/L*h | LEAST_SQUARES_MEAN |
| SECONDARY | Efficacy of Pramlintide by Measurement of Absolute Plasma Glucose Area Under the Plasma Concentration-time Curve (AUC) Following Breakfast | 2 hours | Pharmacokinetic/Pharmacodynamic (PK/PD) Analysis Set: Of the 33 correctly randomized subjects, 26 (76.5%) subjects received at least 1 dose of pramlintide and had evaluable PD data and were, therefore, included in the PK/PD Analysis Set. | mmol/L*h | LEAST_SQUARES_MEAN |
| SECONDARY | Efficacy of Pramlintide by Measurement of Incremental 24-hour Tissue Glucose Area Under the Plasma Concentration-time Curve (AUC) Obtained With Continuous Glucose Monitoring (CGM) | 24 h | Full Analysis Set: Of the 33 correctly randomized subjects, 26 (76.5%) had at least 1 efficacy assessment available from each of the 2 crossover periods and were included in the Full Analysis Set, | mg/dL*min | LEAST_SQUARES_MEAN |
| SECONDARY | Efficacy of Pramlintide by Measurement of Absolute 24-hour Plasma Glucose Area Under the Plasma Concentration-time Curve (AUC) | 24 h | Pharmacokinetic/Pharmacodynamic (PK/PD) Analysis Set: Of the 33 correctly randomized subjects, 26 (76.5%) subjects received at least 1 dose of pramlintide and had evaluable PD data and were, therefore, included in the PK/PD Analysis Set. | mmol/L*h | LEAST_SQUARES_MEAN |
| SECONDARY | Efficacy of Pramlintide by Measurement of Incremental 24-hour Plasma Glucose Area Under the Plasma Concentration-time Curve (AUC) | 24 hours | Pharmacokinetic/Pharmacodynamic (PK/PD) Analysis Set: Of the 33 correctly randomized subjects, 26 (76.5%) subjects received at least 1 dose of pramlintide and had evaluable PD data and were, therefore, included in the PK/PD Analysis Set. | mmol/L*h | MEAN |
| SECONDARY | Efficacy of Pramlintide Measured by Percent Time Spent in the Range of >70 mg/dL to <180 mg/dL Tissue Glucose Obtained With Continuous Glucose Monitoring (CGM) | 24 h | Full Analysis Set:Of the 33 correctly randomized subjects, 26 (76.5%) had at least 1 efficacy assessment available from each of the 2 crossover periods and were included in the Full Analysis Set. | Percentage of time | LEAST_SQUARES_MEAN |
| SECONDARY | Efficacy of Pramlintide by Measurement of Absolute 24-hour Plasma Glucagon Area Under the Plasma Concentration-time Curve (AUC) | 24 h | Pharmacokinetic/Pharmacodynamic (PK/PD) Analysis Set: Of the 33 correctly randomized subjects, 26 (76.5%) subjects received at least 1 dose of pramlintide and had evaluable PD data and were, therefore, included in the PK/PD Analysis Set. | h*pmol/L | LEAST_SQUARES_MEAN |
| SECONDARY | Efficacy of Pramlintide by Measurement of Incremental 24-hour Plasma Glucagon Area Under the Plasma Concentration-time Curve (AUC) | 24 h | Pharmacokinetic/Pharmacodynamic (PK/PD) Analysis Set: Of the 33 correctly randomized subjects, 26 (76.5%) subjects received at least 1 dose of pramlintide and had evaluable PD data and were, therefore, included in the PK/PD Analysis Set. | pmol/L*h | MEAN |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group30
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Efficacy of Pramlintide by Measurement of 24-hour Tissue Mean Weighted Glucose (MWG) Obtained With Continuous Glucose Monitoring (CGM) | Placebo & Regular Insulin | 173.8 | Standard Error 8.17 | mg/dL | |
| Efficacy of Pramlintide by Measurement of 24-hour Tissue Mean Weighted Glucose (MWG) Obtained With Continuous Glucose Monitoring (CGM) | Pramlintide & Regular Insulin | 152.2 | Standard Error 8.17 | mg/dL | |
| Efficacy of Pramlintide by Measurement of Absolute Plasma Glucose Area Under the Plasma Concentration-time Curve (AUC) Following Lunch | Placebo & Regular Insulin | 36.233 | 95% Confidence Interval 31.427 to 41.039 | mmol/L*h | |
| Efficacy of Pramlintide by Measurement of Absolute Plasma Glucose Area Under the Plasma Concentration-time Curve (AUC) Following Lunch | Pramlintide & Regular Insulin | 28.336 | 95% Confidence Interval 23.487 to 33.185 | mmol/L*h | |
| Efficacy of Pramlintide by Measurement of Absolute Plasma Glucose Area Under the Plasma Concentration-time Curve (AUC) Following Dinner | Placebo & Regular Insulin | 23.247 | 95% Confidence Interval 20.472 to 26.021 | mmol/L*h | |
| Efficacy of Pramlintide by Measurement of Absolute Plasma Glucose Area Under the Plasma Concentration-time Curve (AUC) Following Dinner | Pramlintide & Regular Insulin | 17.970 | 95% Confidence Interval 15.231 to 20.709 | mmol/L*h | |
| Efficacy of Pramlintide by Measurement of Absolute Plasma Glucose Area Under the Plasma Concentration-time Curve (AUC) Following Breakfast | Placebo & Regular Insulin | 23.535 | 95% Confidence Interval 20.817 to 26.253 | mmol/L*h | |
| Efficacy of Pramlintide by Measurement of Absolute Plasma Glucose Area Under the Plasma Concentration-time Curve (AUC) Following Breakfast | Pramlintide & Regular Insulin | 19.101 | 95% Confidence Interval 16.280 to 21.922 | mmol/L*h | |
| Efficacy of Pramlintide by Measurement of Incremental 24-hour Tissue Glucose Area Under the Plasma Concentration-time Curve (AUC) Obtained With Continuous Glucose Monitoring (CGM) | Placebo & Regular Insulin | 26243 | Standard Error 3379.8 | mg/dL*min | |
| Efficacy of Pramlintide by Measurement of Incremental 24-hour Tissue Glucose Area Under the Plasma Concentration-time Curve (AUC) Obtained With Continuous Glucose Monitoring (CGM) | Pramlintide & Regular Insulin | -2489 | Standard Error 3379.8 | mg/dL*min |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period 1 | STARTED | Pramlintide First, Then Placebo | 16 | |
| Period 1 | STARTED | Placebo First, Then Pramlintide | 17 | |
| Period 1 | COMPLETED | Pramlintide First, Then Placebo | 12 | |
| Period 1 | COMPLETED | Placebo First, Then Pramlintide | 16 | |
| Period 1 | NOT COMPLETED | Pramlintide First, Then Placebo | 4 | |
| Period 1 | NOT COMPLETED | Placebo First, Then Pramlintide | 1 | |
| Period 2 | STARTED | Pramlintide First, Then Placebo | 12 | |
| Period 2 | STARTED | Placebo First, Then Pramlintide | 16 | |
| Period 2 | COMPLETED | Pramlintide First, Then Placebo | 11 | |
| Period 2 | COMPLETED | Placebo First, Then Pramlintide | 16 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events52
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Placebo & Regular Insulin | 4 | 28 | 4 |
| other | Anaemia | Blood and lymphatic system disorders | Pramlintide & Regular Insulin | 0 | 32 | 0 |
| other | Vomiting | Gastrointestinal disorders | Placebo & Regular Insulin | 0 | 28 | 0 |
| other | Vomiting | Gastrointestinal disorders | Pramlintide & Regular Insulin | 6 | 32 | 6 |
| other | Nausea | Gastrointestinal disorders | Placebo & Regular Insulin | 2 | 28 | 2 |
| other | Nausea | Gastrointestinal disorders | Pramlintide & Regular Insulin | 14 | 32 | 14 |
| other | Cardiovascular disorder | Cardiac disorders | Placebo & Regular Insulin | 0 | 28 | 0 |
| other | Cardiovascular disorder | Cardiac disorders | Pramlintide & Regular Insulin | 1 | 32 | 1 |
| other | Vitreous Detachment | Eye disorders | Placebo & Regular Insulin | 1 | 28 | 1 |
| other | Vitreous Detachment | Eye disorders | Pramlintide & Regular Insulin | 0 | 32 | 0 |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo & Regular Insulin | ||
| Total, all-cause mortality | Pramlintide & Regular Insulin | ||
| Total, other adverse events | Placebo & Regular Insulin | 9 | 28 |
| Total, other adverse events | Pramlintide & Regular Insulin | 22 | 32 |
| Total, serious adverse events | Placebo & Regular Insulin | 0 | 28 |
| Total, serious adverse events | Pramlintide & Regular Insulin | 0 | 32 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30213882 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Placebo & Regular Insulin vs Pramlintide & Regular Insulin: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02500979
GET https://conductscience.org/api/trials/v1/NCT02500979/results?page=2