Trial · NCT00819741
Comparison of the Blood Sugar Lowering Effect Between Repaglinide Plus Metformin and Repaglinide Alone in Type 2 Diabetics Not Previously Treated With Oral Sugar-lowering Drugs
NCT00819741, Phase 4, Completed, Novo Nordisk A/S; results first posted 2010-12-08
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Comparison of the Blood Sugar Lowering Effect Between Repaglinide Plus Metformin and Repaglinide Alone in Type 2 Diabetics Not Previously Treated With Oral Sugar-lowering Drugs. Trials, record NCT00819741. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00819741
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparison of the Blood Sugar Lowering Effect Between Repaglinide Plus Metformin and Repaglinide Alone in Type 2 Diabetics Not Previously Treated With Oral Sugar-lowering Drugs
- NCT number
- NCT00819741
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 433 participants, actual
- Lead sponsor
- Novo Nordisk A/S
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Interventions
- repaglinide, metformin, repaglinide
- First posted
- 2009-01-09
- Last updated
- 2017-02-10
- Results first posted
- 2010-12-08
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 Glycosylated Haemoglobin A1c (HbA1c) | week -2 (screening), week 16 | Calculated as an estimate of the mean change in HbA1c after 16 weeks of treatment. |
| Secondary | Change in Fasting Plasma Glucose | week 0, week 16 | Calculated as an estimate of the mean change in fasting plasma glucose after 16 weeks of treatment. |
| Secondary | Change in 2-hour Postprandial Plasma Glucose | Week 0, week 16 | Calculated as an estimate of the mean change in 2-hour postprandial plasma glucose following a standard test meal after 16 weeks of treatment |
| Secondary | Change in 7-point Plasma Glucose Profile | Week 0, week 16 | Calculated as an estimate of the mean change in 7-point (before breakfast, 2 hours after breakfast, before lunch, 2 hours after lunch, before dinner, 2 hours after dinner, bedtime) plasma glucose profile after 16 weeks of treatment. |
| Secondary | Change in Fasting Serum Insulin | Week 0, week 16 | Calculated as an estimate of the mean change in fasting serum insulin after 16 weeks of treatment. |
| Secondary | Change in 2-hour Postprandial Serum Insulin | Week 0, week 16 | Calculated as an estimate of the mean change in 2-hour postprandial serum insulin after 16 weeks of treatment. |
| Secondary | Change in Fasting Serum C-peptide | Week 0, week 16 | Calculated as an estimate of the mean change in fasting serum C-peptide after 16 weeks of treatment |
| Secondary | Change in 2-hour Postprandial Serum C-peptide | Week 0, week 16 | Calculated as an estimate of the mean change in 2-hour postprandial serum C-peptide after 16 weeks of treatment |
| Secondary | Hypoglycaemic Episodes | Weeks 0-16 | Number of hypoglycaemic episodes from Week 0 to Week 16, defined as major, minor or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L. |
| Secondary | Change in Blood Pressure | Week 0, week 16 | Calculated as the mean change in diastolic and systolic blood pressure after 16 weeks of treatment |
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 Glycosylated Haemoglobin A1c (HbA1c) | week -2 (screening), week 16 | Intention-to-Treat analysis set (ITT) is all subjects who entered the trial treatment period and exposed to at least one dose of trial product. | percentage (%) of total haemoglobin | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Fasting Plasma Glucose | week 0, week 16 | Intention-to-Treat analysis set (ITT) is all subjects who entered the trial treatment period and exposed to at least one dose of trial product. | mmol/L | LEAST_SQUARES_MEAN |
| SECONDARY | Change in 2-hour Postprandial Plasma Glucose | Week 0, week 16 | Intention-to-Treat analysis set (ITT) is all subjects who entered the trial treatment period and exposed to at least one dose of trial product. | mmol/L | LEAST_SQUARES_MEAN |
| SECONDARY | Change in 7-point Plasma Glucose Profile | Week 0, week 16 | Intention-to-Treat analysis set (ITT) is all subjects who entered the trial treatment period and exposed to at least one dose of trial product. | mmol/L | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Fasting Serum Insulin | Week 0, week 16 | Intention-to-Treat analysis set (ITT) is all subjects who entered the trial treatment period and exposed to at least one dose of trial product. A total of 100 subjects (50 per study group) out of the total subjects were randomly selected in the trial. Four trial sites were selected for the subgroup study. | mU/L | LEAST_SQUARES_MEAN |
| SECONDARY | Change in 2-hour Postprandial Serum Insulin | Week 0, week 16 | Intention-to-Treat analysis set (ITT) is all subjects who entered the trial treatment period and exposed to at least one dose of trial product. A total of 100 subjects (50 per study group) out of the total subjects were randomly selected in the trial. Four trial sites were selected for the subgroup study. | mU/L | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Fasting Serum C-peptide | Week 0, week 16 | Intention-to-Treat analysis set (ITT) is all subjects who entered the trial treatment period and exposed to at least one dose of trial product. A total of 100 subjects (50 per study group) out of the total subjects were randomly selected in the trial. Four trial sites were selected for the subgroup study. | ng/ml | LEAST_SQUARES_MEAN |
| SECONDARY | Change in 2-hour Postprandial Serum C-peptide | Week 0, week 16 | Intention-to-Treat analysis set (ITT) is all subjects who entered the trial treatment period and exposed to at least one dose of trial product. A total of 100 subjects (50 per study group) out of the total subjects were randomly selected in the trial. Four trial sites were selected for the subgroup study. | ng/ml | LEAST_SQUARES_MEAN |
| SECONDARY | Hypoglycaemic Episodes | Weeks 0-16 | Safety analysis set was defined as all randomised and exposed subjects. | episodes | NUMBER |
| SECONDARY | Change in Blood Pressure | Week 0, week 16 | Safety analysis set was defined as all randomised and exposed subjects. | mmHg | 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 Glycosylated Haemoglobin A1c (HbA1c) | Repaglinide + Metformin | -4.450 | Standard Error 0.070 | percentage (%) of total haemoglobin | |
| Change in Glycosylated Haemoglobin A1c (HbA1c) | Repaglinide | -4.148 | Standard Error 0.071 | percentage (%) of total haemoglobin | |
| Change in Fasting Plasma Glucose | Repaglinide + Metformin | -4.646 | Standard Error 0.129 | mmol/L | |
| Change in Fasting Plasma Glucose | Repaglinide | -3.982 | Standard Error 0.130 | mmol/L | |
| Change in 2-hour Postprandial Plasma Glucose | Repaglinide + Metformin | -7.525 | Standard Error 0.237 | mmol/L | |
| Change in 2-hour Postprandial Plasma Glucose | Repaglinide | -6.794 | Standard Error 0.242 | mmol/L | |
| Change in 7-point Plasma Glucose Profile | Repaglinide + Metformin | Before breakfast, N=204, 199 | -4.99 | Standard Error 0.11 | mmol/L |
| Change in 7-point Plasma Glucose Profile | Repaglinide | Before breakfast, N=204, 199 | -4.58 | Standard Error 0.12 | mmol/L |
| Change in 7-point Plasma Glucose Profile | Repaglinide + Metformin | 2 hours after breakfast, N=206, 201 | -7.85 | Standard Error 0.23 | mmol/L |
| Change in 7-point Plasma Glucose Profile | Repaglinide | 2 hours after breakfast, N=206, 201 | -7.40 | Standard Error 0.24 | mmol/L |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Repaglinide + Metformin | 218 | |
| Overall Study | STARTED | Repaglinide | 215 | |
| Overall Study | Exposed to Drug | Repaglinide + Metformin | 218 | |
| Overall Study | Exposed to Drug | Repaglinide | 214 | |
| Overall Study | COMPLETED | Repaglinide + Metformin | 196 | |
| Overall Study | COMPLETED | Repaglinide | 201 | |
| Overall Study | NOT COMPLETED | Repaglinide + Metformin | 22 | |
| Overall Study | NOT COMPLETED | Repaglinide | 14 |
Source ClinicalTrials.gov
Adverse events2
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 |
|---|---|---|---|---|---|---|
| serious | Anxiety | Psychiatric disorders | Repaglinide + Metformin | 0 | 218 | 0 |
| serious | Anxiety | Psychiatric disorders | Repaglinide | 1 | 214 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Repaglinide + Metformin | ||
| Total, all-cause mortality | Repaglinide | ||
| Total, other adverse events | Repaglinide + Metformin | 0 | 218 |
| Total, other adverse events | Repaglinide | 0 | 214 |
| Total, serious adverse events | Repaglinide + Metformin | 0 | 218 |
| Total, serious adverse events | Repaglinide | 1 | 214 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 21780853 | RESULT |
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 |
|---|
| Repaglinide + Metformin vs Repaglinide: 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/NCT00819741
GET https://conductscience.org/api/trials/v1/NCT00819741/results?page=2