Trial · NCT01030952
Effects of Nateglinide on Postprandial Glucose Excursion by Restoring Early Phase Insulin Secretion
NCT01030952, Phase 4, Completed, Novartis Pharmaceuticals; results first posted 2012-10-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Effects of Nateglinide on Postprandial Glucose Excursion by Restoring Early Phase Insulin Secretion. Trials, record NCT01030952. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01030952
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effects of Nateglinide on Postprandial Glucose Excursion by Restoring Early Phase Insulin Secretion
- NCT number
- NCT01030952
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 103 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Nateglinide, Acarbose
- First posted
- 2009-12-14
- Last updated
- 2012-10-19
- Results first posted
- 2012-10-19
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Area Under Curve of 0-4 Hours Postprandial Glucose (AUCpp0-4hours) in Standardized Meal Test Using Continuous Glucose Monitoring System (CGMS) | 3 weeks (end of study) minus baseline | The postprandial glucose area under the curve (AUC)was calculated using values from the 3 time points. Participants were fasting (no calorie intake for at least 8 hours prior to the meal test) and completed the standardized meal test between 7 and 10 AM. 0-4 hours AUC were calculated using trapezoid methods. |
| Secondary | Change in Incremental Glucose Peak (IGP) From Baseline | baseline, 3 weeks (end of study) | Incremental glucose peak (IGP) was the maximal incremental increase in blood glucose obtained at any point after meal |
| Secondary | Change in Mean Blood Glucose (MBG) | baseline and at 3 weeks (end of study) | The 24 hour mean blood glucose (MBG) level was calculated as the mean of all the consecutive readings on baseline and end of study(3 weeks later) separately. |
| Secondary | Change in Standard Deviation (SD) From Baseline of Mean Blood Glucose (MBG) Over 24 Hours. | baseline, 3 weeks (end of study) | Change in standard deviation (SD) from baseline of mean blood glucose (MBG) describes the range of blood glucose fluctuation over 24 hours. |
| Secondary | Change in Mean of Daily Difference of Paired Blood Glucose Value (MODD) | baseline, 3 weeks (end of study) | The mean of the daily differences (MODD), calculated as the average absolute difference of paired glucose values during two successive 24 hour periods, was used to assess day-to-day glycaemic variability. |
| Secondary | Changes in 24 Hour Glucose Area Under Curve (AUCpp) | baseline, end of study (3 weeks) | Blood samples were collected for measurement of plasma glucose at 30, 60, 90, and 120 minutes following the start of a standardized meal test at Baseline and Week 4. The postprandial glucose area under the curve was calculated using values from the 4 time points. Participants were fasting (no calorie intake for at least 8 hours prior to the meal test) and completed the standardized meal test between 7 and 10 AM. |
| Secondary | Change in Glycated Serum Albumin (GSA) Levels From Baseline After Treatment | baseline, 3 weeks (end of study) | GSA levels were to be determined by CGMS at 7:00\~10:00 am in the 4-hour standardized meal test before treatment after overnight fasting for efficacy assessments |
| Secondary | Change in Insulin Levels (μU/ml) During Standardized Meal Test at Endpoint From Baseline | baseline, 3 weeks (end of study) | This outcome measure calculated the change in insulin levels between groups over time at 0, 30 then 120 minutes |
| Secondary | Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) | baseline, 3 weeks (end of study) | change in LDL-C at 0, 30 and 120 minutes |
| Secondary | Change of Total Cholesterol in Blood Lipids Levels During Standardized Meal Test at Endpoint From Baseline at Each Time Point | baseline, 3 weeks (end of study) | time to change in Total Cholesterol blood lipids level at 0, 30, 120 minutes |
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 | Change in Area Under Curve of 0-4 Hours Postprandial Glucose (AUCpp0-4hours) in Standardized Meal Test Using Continuous Glucose Monitoring System (CGMS) | 3 weeks (end of study) minus baseline | Intent to Treat population - All patients who received at least one dose of study drug after random allocation and had at least one primary or secondary efficacy evaluation after baseline. | millimoles hours per litre (mmol*hr/L) | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Incremental Glucose Peak (IGP) From Baseline | baseline, 3 weeks (end of study) | Intent to Treat population - All patients who received at least one dose of study drug after random allocation and had at least one primary or secondary efficacy evaluation after baseline. | millimoles per litre (mmol/L) | MEAN |
| SECONDARY | Change in Mean Blood Glucose (MBG) | baseline and at 3 weeks (end of study) | Intent to Treat population - All patients who received at least one dose of study drug after random allocation and had at least one primary or secondary efficacy evaluation after baseline | millimoles per litre (mmol/l) | MEAN |
| SECONDARY | Change in Standard Deviation (SD) From Baseline of Mean Blood Glucose (MBG) Over 24 Hours. | baseline, 3 weeks (end of study) | Intent to Treat population - All patients who received at least one dose of study drug after random allocation and had at least one primary or secondary efficacy evaluation after baseline | mmol/l | MEAN |
| SECONDARY | Change in Mean of Daily Difference of Paired Blood Glucose Value (MODD) | baseline, 3 weeks (end of study) | Intent-to treat population (ITT): All randomized participants who received at least 1 dose of study drug, had valid baseline data, and at least 1 post-baseline assessment of the primary efficacy variable. | millimoles per litre (mmol/l) | MEAN |
| SECONDARY | Changes in 24 Hour Glucose Area Under Curve (AUCpp) | baseline, end of study (3 weeks) | Intent-to treat population (ITT): All randomized participants who received at least 1 dose of study drug, had valid baseline data, and at least 1 post-baseline assessment of the primary efficacy variable. | mmol*min/L | MEAN |
| SECONDARY | Change in Glycated Serum Albumin (GSA) Levels From Baseline After Treatment | baseline, 3 weeks (end of study) | Intent to Treat population - All patients who received at least one dose of study drug after random allocation and had at least one primary or secondary efficacy evaluation after baseline. During different time points, participants with observations at that time point were included in the analysis. | percent | MEAN |
| SECONDARY | Change in Insulin Levels (μU/ml) During Standardized Meal Test at Endpoint From Baseline | baseline, 3 weeks (end of study) | The Intent to Treat (ITT) population consists of all patients randomized and who have at least one dose of study medication. | (μU/ml) | MEAN |
| SECONDARY | Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) | baseline, 3 weeks (end of study) | Intent to Treat population - All patients who received at least one dose of study drug after random allocation and had at least one primary or secondary efficacy evaluation after baseline. During different time points, participants with observations at that time point were included in the analysis. | millimoles per litre (mmol/l) | MEAN |
| SECONDARY | Change of Total Cholesterol in Blood Lipids Levels During Standardized Meal Test at Endpoint From Baseline at Each Time Point | baseline, 3 weeks (end of study) | The Intent to Treat (ITT) population consists of all patients randomized and who have at least one dose of study medication. | millimoles per litre (mmol/l) | MEAN |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group50
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Area Under Curve of 0-4 Hours Postprandial Glucose (AUCpp0-4hours) in Standardized Meal Test Using Continuous Glucose Monitoring System (CGMS) | Nateglinide | -9.20 | 95% Confidence Interval 11.71 | millimoles hours per litre (mmol*hr/L) | |
| Change in Area Under Curve of 0-4 Hours Postprandial Glucose (AUCpp0-4hours) in Standardized Meal Test Using Continuous Glucose Monitoring System (CGMS) | Acarbose | -9.92 | 95% Confidence Interval 9.97 | millimoles hours per litre (mmol*hr/L) | |
| Change in Incremental Glucose Peak (IGP) From Baseline | Nateglinide | -2.72 | Standard Deviation 2.86 | millimoles per litre (mmol/L) | |
| Change in Incremental Glucose Peak (IGP) From Baseline | Acarbose | -1.89 | Standard Deviation 2.76 | millimoles per litre (mmol/L) | |
| Change in Mean Blood Glucose (MBG) | Nateglinide | -1.16 | Standard Deviation 1.24 | millimoles per litre (mmol/l) | |
| Change in Mean Blood Glucose (MBG) | Acarbose | -0.78 | Standard Deviation 1.29 | millimoles per litre (mmol/l) | |
| Change in Standard Deviation (SD) From Baseline of Mean Blood Glucose (MBG) Over 24 Hours. | Nateglinide | -0.48 | Standard Deviation 0.63 | mmol/l | |
| Change in Standard Deviation (SD) From Baseline of Mean Blood Glucose (MBG) Over 24 Hours. | Acarbose | -0.63 | Standard Deviation 0.59 | mmol/l | |
| Change in Mean of Daily Difference of Paired Blood Glucose Value (MODD) | Nateglinide | -0.06 | Standard Deviation 0.95 | millimoles per litre (mmol/l) | |
| Change in Mean of Daily Difference of Paired Blood Glucose Value (MODD) | Acarbose | -0.21 | Standard Deviation 0.86 | millimoles per litre (mmol/l) |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Nateglinide | 51 | |
| Overall Study | STARTED | Acarbose | 52 | |
| Overall Study | COMPLETED | Nateglinide | 49 | |
| Overall Study | COMPLETED | Acarbose | 49 | |
| Overall Study | NOT COMPLETED | Nateglinide | 2 | |
| Overall Study | NOT COMPLETED | Acarbose | 3 |
Source ClinicalTrials.gov
Adverse events30
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 | Abdominal distension | Gastrointestinal disorders | Nateglinide | 0 | 51 | |
| other | Abdominal distension | Gastrointestinal disorders | Acarbose | 4 | 52 | |
| other | Frequency bowel movements | Gastrointestinal disorders | Nateglinide | 0 | 51 | |
| other | Frequency bowel movements | Gastrointestinal disorders | Acarbose | 2 | 52 | |
| other | Gastrointestinal flatulence | Gastrointestinal disorders | Nateglinide | 0 | 51 | |
| other | Gastrointestinal flatulence | Gastrointestinal disorders | Acarbose | 7 | 52 | |
| other | Hypoglycemia | Metabolism and nutrition disorders | Nateglinide | 3 | 51 | |
| other | Hypoglycemia | Metabolism and nutrition disorders | Acarbose | 0 | 52 | |
| other | Upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | Nateglinide | 0 | 51 | |
| other | Upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | Acarbose | 2 | 52 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Nateglinide | ||
| Total, all-cause mortality | Acarbose | ||
| Total, other adverse events | Nateglinide | 7 | 51 |
| Total, other adverse events | Acarbose | 16 | 52 |
| Total, serious adverse events | Nateglinide | 0 | 51 |
| Total, serious adverse events | Acarbose | 0 | 52 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
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 |
|---|
| Nateglinide vs Acarbose: 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/NCT01030952
GET https://conductscience.org/api/trials/v1/NCT01030952/results?page=2