Trial · NCT01644500
A Study Comparing the Effects and Safety of Dulaglutide With Glimepiride in Type 2 Diabetes Mellitus
NCT01644500, Phase 3, Completed, Eli Lilly and Company; results first posted 2015-12-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study Comparing the Effects and Safety of Dulaglutide With Glimepiride in Type 2 Diabetes Mellitus. Trials, record NCT01644500. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01644500
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study Comparing the Effects and Safety of Dulaglutide With Glimepiride in Type 2 Diabetes Mellitus
- NCT number
- NCT01644500
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 737 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Dulaglutide, Glimepiride, Placebo as Capsules, Placebo as SC Injection
- First posted
- 2012-07-19
- Last updated
- 2019-09-18
- Results first posted
- 2015-12-17
Source ClinicalTrials.gov
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in HbA1c at 26 Weeks | Baseline, 26 Weeks | HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) analysis adjusting for treatment, country, pre-study therapy stratum, visit, and treatment-by-visit as fixed effects; baseline HbA1c as covariate; and participant as a random effect. |
| Secondary | Percentage of Participants Attaining HbA1c of <7% or ≤6.5% at 26 Weeks | 26 Weeks | Percentages of participants who achieved HbA1c levels of \<7% or ≤6.5% were analyzed using a logistic regression model, controlling for treatment, pre-treatment, baseline HbA1c and country. |
| Secondary | Change From Baseline in Fasting Blood Glucose (FBG) at 26 Weeks | Baseline, 26 Weeks | FBG is a test to determine how much glucose (sugar) is in a blood sample after an overnight fast. FBG was measured by a central laboratory. LS means were calculated using MMRM analysis adjusting for treatment, country, pre-study therapy stratum, visit, and treatment-by-visit as fixed effects; baseline FBG as covariate; and participant as a random effect. |
| Secondary | Change From Baseline in 7-point Self-monitored Blood Glucose (SMBG) Profiles at 26 Weeks | Baseline, 26 Weeks | Change from baseline in mean daily blood glucose (BG) values were measured with a 7-point SMBG profile. Participants recorded their 7-point SMBG profiles on 2 separate, non-consecutive days during the 2-week period immediately before randomization, Week 8, Week 16, and Week 26 (or the Early Discontinuation Visit). The 7-point SMBG profile consisted of pre-prandial BG measures before the morning (fasting), midday, and evening meals; BG measures 2 hours after the start (post-prandial) of the morning, midday, and evening meals; and BG measures at bedtime. Mean at 26 weeks was assessed in all treatment groups. LS means were calculated using MMRM analysis adjusting for treatment, country, pre-study therapy stratum, visit, and treatment-by-visit as fixed effects; baseline body weight as covariate; and participant as a random effect. |
| Secondary | Rate of Hypoglycemic Episodes | Baseline through 26 Weeks | Hypoglycemic episodes are defined as events that are associated with reported signs and symptoms of hypoglycemia and/or documented BG concentrations of ≤70 milligrams per deciliter (mg/dL) (≤3.9 mmol/L). A severe hypoglycemic episode was defined as any hypoglycemic event for which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Nocturnal hypoglycemia is defined as any hypoglycemic event that occurs between bedtime and waking. Log mean rates of total hypoglycemia (per 30 days per participant) are presented and were calculated from negative binomial regression model. The model included country/region, prior medication group, treatment, visit, and treatment-by-visit interaction. The logarithm of days between visits was adjusted as an offset to account for possible unequal duration between visits and between participants. |
| Secondary | Number of Participants With Self-Reported Hypoglycemic Episodes | Baseline through 26 Weeks | The overall number of participants with self-reported hypoglycemic episodes is presented. |
| Secondary | Change From Baseline in Homeostasis Model Assessment 2 Steady-state Beta (β) - Cell Function (HOMA2-%B) at 26 Weeks | Baseline, up to 26 Weeks | Change from baseline in HOMA2-%B was assessed by using the homeostasis model assessment (HOMA) to quantify β-cell function. HOMA2-%B is a computer model that uses FBG, insulin, and C-peptide concentrations to estimate steady state β-cell function (%B) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. LS means were calculated using an analysis of covariance (ANCOVA) model with country, baseline, pre-treatment, and treatment as fixed effects. |
| Secondary | Change From Baseline in Homeostasis Model Assessment 2 Insulin Sensitivity - Cell Function (HOMA2-%S) at 26 Weeks | Baseline, up to 26 Weeks | Change from baseline in HOMA2-%S was assessed by using the HOMA to quantify insulin sensitivity. HOMA2-%S is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady state insulin sensitivity (%S) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. LS means were calculated using an ANCOVA model with country, baseline, pre-treatment, and treatment as fixed effects. |
| Secondary | Change From Baseline in Pancreatic Enzymes at 26 Weeks | Baseline, 26 Weeks | Amylase (total and pancreas-derived) and lipase concentrations were measured. |
| Secondary | Change From Baseline in Serum Calcitonin at 26 Weeks | Baseline, 26 Weeks |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 registered outcomesOutcomes21
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in HbA1c at 26 Weeks | Baseline, 26 Weeks | Participants who had been randomized, received at least one dose of study drug, had a baseline HbA1c measurement, and had at least one post-baseline HbA1c measurement. | percentage of HbA1c | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants Attaining HbA1c of <7% or ≤6.5% at 26 Weeks | 26 Weeks | Participants who had been randomized, received at least one dose of study drug, had a baseline HbA1c measurement, and had at least one post-baseline HbA1c measurement. Last observation carried forward (LOCF) methodology was used to impute missing post-baseline values. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Fasting Blood Glucose (FBG) at 26 Weeks | Baseline, 26 Weeks | Participants who had been randomized, received at least one dose of study drug, had a baseline HbA1c measurement, and had at least one post-baseline HbA1c measurement. | millimoles per liter (mmol/L) | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in 7-point Self-monitored Blood Glucose (SMBG) Profiles at 26 Weeks | Baseline, 26 Weeks | Participants who had been randomized, received at least one dose of study drug, had a baseline HbA1c measurement, and had at least one post-baseline HbA1c measurement. | mmol/L | LEAST_SQUARES_MEAN |
| SECONDARY | Rate of Hypoglycemic Episodes | Baseline through 26 Weeks | Participants who had been randomized, received at least one dose of study drug, and had evaluable hypoglycemic data. | episodes/participant/30 days | MEAN |
| SECONDARY | Number of Participants With Self-Reported Hypoglycemic Episodes | Baseline through 26 Weeks | All participants who were randomized and received at least one dose of study drug. | participants | NUMBER |
| SECONDARY | Change From Baseline in Homeostasis Model Assessment 2 Steady-state Beta (β) - Cell Function (HOMA2-%B) at 26 Weeks | Baseline, up to 26 Weeks | Participants who had been randomized, received at least one dose of study drug, had a baseline HbA1c measurement, and had at least one post-baseline HbA1c measurement. LOCF methodology was used to impute missing post-baseline values. | percentage of HOMA2-%B | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Homeostasis Model Assessment 2 Insulin Sensitivity - Cell Function (HOMA2-%S) at 26 Weeks | Baseline, up to 26 Weeks | Participants who had been randomized, received at least one dose of study drug, had a baseline HbA1c measurement, and had at least one post-baseline HbA1c measurement. LOCF methodology was used to impute missing post-baseline values. | percentage of HOMA2-%S | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Pancreatic Enzymes at 26 Weeks | Baseline, 26 Weeks | Participants who had been randomized, received at least one dose of study drug, had a baseline HbA1c measurement, had at least one post-baseline HbA1c measurement and had evaluable pancreatic enzyme data. | units per liter (u/L) | MEAN |
| SECONDARY | Change From Baseline in Serum Calcitonin at 26 Weeks | Baseline, 26 Weeks | Participants who had been randomized, received at least one dose of study drug, had a baseline HbA1c measurement, had at least one post-baseline HbA1c measurement, and had evaluable serum calcitonin data. | picomoles per liter (pmol/L) | MEAN |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 outcomesResults by group180
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in HbA1c at 26 Weeks | 1.5 mg Dulaglutide | -1.48 | Standard Error 0.069 | percentage of HbA1c | |
| Change From Baseline in HbA1c at 26 Weeks | 0.75 mg Dulaglutide | -1.22 | Standard Error 0.069 | percentage of HbA1c | |
| Change From Baseline in HbA1c at 26 Weeks | Glimepiride | -0.92 | Standard Error 0.069 | percentage of HbA1c | |
| Percentage of Participants Attaining HbA1c of <7% or ≤6.5% at 26 Weeks | 1.5 mg Dulaglutide | HbA1c ≤6.5% | 59.4 | percentage of participants | |
| Percentage of Participants Attaining HbA1c of <7% or ≤6.5% at 26 Weeks | 0.75 mg Dulaglutide | HbA1c ≤6.5% | 47.7 | percentage of participants | |
| Percentage of Participants Attaining HbA1c of <7% or ≤6.5% at 26 Weeks | Glimepiride | HbA1c ≤6.5% | 41.3 | percentage of participants | |
| Percentage of Participants Attaining HbA1c of <7% or ≤6.5% at 26 Weeks | 1.5 mg Dulaglutide | HbA1c <7.0% | 74.1 | percentage of participants | |
| Percentage of Participants Attaining HbA1c of <7% or ≤6.5% at 26 Weeks | 0.75 mg Dulaglutide | HbA1c <7.0% | 63.6 | percentage of participants | |
| Percentage of Participants Attaining HbA1c of <7% or ≤6.5% at 26 Weeks | Glimepiride | HbA1c <7.0% | 57.4 | percentage of participants | |
| Change From Baseline in Fasting Blood Glucose (FBG) at 26 Weeks | 1.5 mg Dulaglutide | -2.71 | Standard Error 0.135 | millimoles per liter (mmol/L) |
1 to 10 of 180Source ClinicalTrials.gov
See all 180 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 1.5 mg Dulaglutide | 244 | |
| Overall Study | STARTED | 0.75 mg Dulaglutide | 248 | |
| Overall Study | STARTED | Glimepiride | 245 | |
| Overall Study | Received at Least One Dose of Study Drug | 1.5 mg Dulaglutide | 244 | |
| Overall Study | Received at Least One Dose of Study Drug | 0.75 mg Dulaglutide | 248 | |
| Overall Study | Received at Least One Dose of Study Drug | Glimepiride | 243 | |
| Overall Study | Modified Intent-to-treat Population | 1.5 mg Dulaglutide | 239 | |
| Overall Study | Modified Intent-to-treat Population | 0.75 mg Dulaglutide | 239 | |
| Overall Study | Modified Intent-to-treat Population | Glimepiride | 242 | |
| Overall Study | COMPLETED | 1.5 mg Dulaglutide | 222 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events771
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 | 1.5 mg Dulaglutide | 0 | 244 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | 0.75 mg Dulaglutide | 1 | 248 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Glimepiride | 1 | 243 | 1 |
| other | Eosinophilia | Blood and lymphatic system disorders | 1.5 mg Dulaglutide | 0 | 244 | 0 |
| other | Eosinophilia | Blood and lymphatic system disorders | 0.75 mg Dulaglutide | 1 | 248 | 1 |
| other | Eosinophilia | Blood and lymphatic system disorders | Glimepiride | 0 | 243 | 0 |
| other | Lymphadenitis | Blood and lymphatic system disorders | 1.5 mg Dulaglutide | 1 | 244 | 1 |
| other | Lymphadenitis | Blood and lymphatic system disorders | 0.75 mg Dulaglutide | 0 | 248 | 0 |
| other | Lymphadenitis | Blood and lymphatic system disorders | Glimepiride | 0 | 243 | 0 |
| other | Atrioventricular block | Cardiac disorders | 1.5 mg Dulaglutide | 0 | 244 | 0 |
1 to 10 of 771Source ClinicalTrials.gov
See all 771 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 1.5 mg Dulaglutide | ||
| Total, all-cause mortality | 0.75 mg Dulaglutide | ||
| Total, all-cause mortality | Glimepiride | ||
| Total, other adverse events | 1.5 mg Dulaglutide | 165 | 244 |
| Total, other adverse events | 0.75 mg Dulaglutide | 141 | 248 |
| Total, other adverse events | Glimepiride | 137 | 243 |
| Total, serious adverse events | 1.5 mg Dulaglutide | 6 | 244 |
| Total, serious adverse events | 0.75 mg Dulaglutide | 4 | 248 |
| Total, serious adverse events | Glimepiride | 3 | 243 |
Source ClinicalTrials.gov
Papers5
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01644500
GET https://conductscience.org/api/trials/v1/NCT01644500/registered?page=2