Trial · NCT00570739
Effects of Metformin Hydrochloride (HCl) in Combination With Colesevelam HCl, Compared to Metformin HCl Alone, in Patients With Type 2 Diabetes Mellitus and the Effects of Colesevelam HCl on Lipids and Glucose on Pre-diabetic Patients.
NCT00570739, Phase 3, Completed, Daiichi Sankyo; results first posted 2010-07-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Effects of Metformin Hydrochloride (HCl) in Combination With Colesevelam HCl, Compared to Metformin HCl Alone, in Patients With Type 2 Diabetes Mellitus and the Effects of Colesevelam HCl on Lipids and Glucose on Pre-diabetic Patients. Trials, record NCT00570739. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00570739
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Effects of Metformin Hydrochloride (HCl) in Combination With Colesevelam HCl, Compared to Metformin HCl Alone, in Patients With Type 2 Diabetes Mellitus and the Effects of Colesevelam HCl on Lipids and Glucose on Pre-diabetic Patients.
- NCT number
- NCT00570739
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 502 participants, actual
- Lead sponsor
- Daiichi Sankyo
- Conditions
- Type 2 Diabetes Mellitus, Hypercholesterolemia, Pre-diabetes
- Interventions
- Metformin HCl and Colesevelam Placebo, Metformin HCl tablets and Colesevelam tablets, Colesevelam placebo, Colesevelam
- First posted
- 2007-12-11
- Last updated
- 2010-07-27
- Results first posted
- 2010-07-13
Source ClinicalTrials.gov
Registered outcomes66
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change of Hemoglobin A1C (HbA1C) From Baseline to 16 Weeks When Given as Initial Therapy to Drug-naïve, Diabetic Subjects. | Baseline to 16 weeks | |
| Primary | Percent Change in Low Density Lipoprotein-Cholesterol (LDL-C) in Pre-Diabetic Subjects From Baseline to 16 Weeks | Baseline to 16 Weeks | |
| Secondary | Percent Change in Hemoglobin A1C (HbA1C) When Given to Drug-naïve, Diabetic Subjects From Baseline to 4, 8, 12 and 16 Weeks. | Baseline to 4, 8, 12, and 16 weeks | |
| Secondary | Fasting Plasma Glucose When Given to Drug-naïve, Diabetic Subjects From Baseline to 4, 8, 12, and 16 Weeks | Baseline to 4, 8, 12, and 16 weeks | |
| Secondary | Fasting Insulin When Given to Drug-naïve, Diabetic Subjects From Baseline to 4, 8, 12, and 16 Weeks | Baseline to 4, 8, 12, and 16 weeks | |
| Secondary | Fasting C-Peptide Levels When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks | Baseline to 16 weeks | |
| Secondary | 30 Minute Post-Meal Glucose Levels When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks | Baseline to 16 weeks | |
| Secondary | 1 Hour Post-Meal Glucose Levels When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks | Baseline to 16 weeks | |
| Secondary | 2 Hour Post-Meal Glucose Levels to in Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks | Baseline to 16 weeks | |
| Secondary | 2 Hour Post-Meal Insulin Levels When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks | Baseline to 16 weeks |
1 to 10 of 66Source ClinicalTrials.gov
See all 66 registered outcomesOutcomes66
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Percent Change in Hemoglobin A1C (HbA1C) When Given to Drug-naïve, Diabetic Subjects From Baseline to 4, 8, 12 and 16 Weeks. | Baseline to 4, 8, 12, and 16 weeks | The number analyzed equals the full analysis set. The full analysis set included all randomized subjects who took at least 1 dose of randomized study medication, and had a baseline and at least 1 post-baseline efficacy variable measurement. This analysis set was used for the summary and analysis of all efficacy variables. LOCF was not used. | Percentage of change in HbA1c | LEAST_SQUARES_MEAN |
| SECONDARY | Fasting Plasma Glucose When Given to Drug-naïve, Diabetic Subjects From Baseline to 4, 8, 12, and 16 Weeks | Baseline to 4, 8, 12, and 16 weeks | The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF. | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Fasting Insulin When Given to Drug-naïve, Diabetic Subjects From Baseline to 4, 8, 12, and 16 Weeks | Baseline to 4, 8, 12, and 16 weeks | The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF. | uIU/mL | LEAST_SQUARES_MEAN |
| SECONDARY | Fasting C-Peptide Levels When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks | Baseline to 16 weeks | The No. analyzed = the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, and had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. Results are presented for both LOCF and no LOCF. | ng/mL | LEAST_SQUARES_MEAN |
| SECONDARY | 30 Minute Post-Meal Glucose Levels When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks | Baseline to 16 weeks | The No. analyzed = the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, and had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. Results are presented for both LOCF and no LOCF. | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | 1 Hour Post-Meal Glucose Levels When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks | Baseline to 16 weeks | The No. analyzed = the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, and had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. Results are presented for both LOCF and no LOCF. | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | 2 Hour Post-Meal Glucose Levels to in Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks | Baseline to 16 weeks | The No. analyzed = the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, and had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. Results are presented for both LOCF and no LOCF. | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | 2 Hour Post-Meal Insulin Levels When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks | Baseline to 16 weeks | The No. analyzed = the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, and had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. Results are presented for both LOCF and no LOCF. | uIU/mL | LEAST_SQUARES_MEAN |
| SECONDARY | 2 Hour Post-Meal C-Peptide Levels When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks | Baseline to 16 weeks | The No. analyzed = the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, and had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. Results are presented for both LOCF and no LOCF. | ng/mL | LEAST_SQUARES_MEAN |
| SECONDARY | The Percent Change of Low Density Lipoprotein Cholesterol (LDL-C) When Given to Drug-naïve, Diabetic Subjects From Baseline to 8, and 16 Weeks | Baseline to 8, and 16 weeks | The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF. | percentage of change in LDL-C | LEAST_SQUARES_MEAN |
1 to 10 of 66Source ClinicalTrials.gov
See all 66 outcomesResults by group492
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change in Hemoglobin A1C (HbA1C) When Given to Drug-naïve, Diabetic Subjects From Baseline to 4, 8, 12 and 16 Weeks. | Type 2 Diabetes Group:Placebo+Metformin | Baseline to 4 weeks:Pla+Met, N=128, Col+Met N=129 | -0.38 | Standard Error 0.044 | Percentage of change in HbA1c |
| Percent Change in Hemoglobin A1C (HbA1C) When Given to Drug-naïve, Diabetic Subjects From Baseline to 4, 8, 12 and 16 Weeks. | Type 2 Diabetes Group:Colesevelam+Metformin | Baseline to 4 weeks:Pla+Met, N=128, Col+Met N=129 | -0.53 | Standard Error 0.044 | Percentage of change in HbA1c |
| Percent Change in Hemoglobin A1C (HbA1C) When Given to Drug-naïve, Diabetic Subjects From Baseline to 4, 8, 12 and 16 Weeks. | Type 2 Diabetes Group:Placebo+Metformin | Baseline to 8 weeks:Pla+Met, N=123, Col+Met N=125 | -0.67 | Standard Error 0.055 | Percentage of change in HbA1c |
| Percent Change in Hemoglobin A1C (HbA1C) When Given to Drug-naïve, Diabetic Subjects From Baseline to 4, 8, 12 and 16 Weeks. | Type 2 Diabetes Group:Colesevelam+Metformin | Baseline to 8 weeks:Pla+Met, N=123, Col+Met N=125 | -0.84 | Standard Error 0.055 | Percentage of change in HbA1c |
| Percent Change in Hemoglobin A1C (HbA1C) When Given to Drug-naïve, Diabetic Subjects From Baseline to 4, 8, 12 and 16 Weeks. | Type 2 Diabetes Group:Placebo+Metformin | Baseline to 12 weeks:Pla+Met, N=115, Col+Met N=123 | -0.86 | Standard Error 0.062 | Percentage of change in HbA1c |
| Percent Change in Hemoglobin A1C (HbA1C) When Given to Drug-naïve, Diabetic Subjects From Baseline to 4, 8, 12 and 16 Weeks. | Type 2 Diabetes Group:Colesevelam+Metformin | Baseline to 12 weeks:Pla+Met, N=115, Col+Met N=123 | -1.05 | Standard Error 0.059 | Percentage of change in HbA1c |
| Percent Change in Hemoglobin A1C (HbA1C) When Given to Drug-naïve, Diabetic Subjects From Baseline to 4, 8, 12 and 16 Weeks. | Type 2 Diabetes Group:Placebo+Metformin | Baseline to 16 weeks:Pla+Met, N=118, Col+Met N=122 | -0.92 | Standard Error 0.064 | Percentage of change in HbA1c |
| Percent Change in Hemoglobin A1C (HbA1C) When Given to Drug-naïve, Diabetic Subjects From Baseline to 4, 8, 12 and 16 Weeks. | Type 2 Diabetes Group:Colesevelam+Metformin | Baseline to 16 weeks:Pla+Met, N=118, Col+Met N=122 | -1.17 | Standard Error 0.063 | Percentage of change in HbA1c |
| Fasting Plasma Glucose When Given to Drug-naïve, Diabetic Subjects From Baseline to 4, 8, 12, and 16 Weeks | Type 2 Diabetes Group: Placebo+Metformin | baseline to 4 weeks Pla+Met N=130, Col+Met N=131 | -19.0 | Standard Error 2.31 | mg/dL |
| Fasting Plasma Glucose When Given to Drug-naïve, Diabetic Subjects From Baseline to 4, 8, 12, and 16 Weeks | Type 2 Diabetes Group:Colesevelam+Metformin | baseline to 4 weeks Pla+Met N=130, Col+Met N=131 | -24.0 | Standard Error 2.30 | mg/dL |
1 to 10 of 492Source ClinicalTrials.gov
See all 492 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Type 2 Diabetes Group: Placebo + Metformin | 141 | |
| Overall Study | STARTED | Type 2 Diabetes Group: Colesevelam + Metformin | 145 | |
| Overall Study | STARTED | Pre-diabetic Group: Placebo | 108 | |
| Overall Study | STARTED | Pre-diabetic Group: Colesevelam | 108 | |
| Overall Study | COMPLETED | Type 2 Diabetes Group: Placebo + Metformin | 120 | |
| Overall Study | COMPLETED | Type 2 Diabetes Group: Colesevelam + Metformin | 124 | |
| Overall Study | COMPLETED | Pre-diabetic Group: Placebo | 92 | |
| Overall Study | COMPLETED | Pre-diabetic Group: Colesevelam | 96 | |
| Overall Study | NOT COMPLETED | Type 2 Diabetes Group: Placebo + Metformin | 21 | |
| Overall Study | NOT COMPLETED | Type 2 Diabetes Group: Colesevelam + Metformin | 21 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events164
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 | Type 2 Diabetes Group: Placebo + Metformin | 5 | 141 | |
| other | Abdominal distension | Gastrointestinal disorders | Type 2 Diabetes Group: Colesevelam + Metformin | 4 | 141 | |
| other | Abdominal distension | Gastrointestinal disorders | Pre-diabetic Group: Placebo | 0 | 108 | |
| other | Abdominal distension | Gastrointestinal disorders | Pre-diabetic Group: Colesevelam | 0 | 107 | |
| other | Abdominal Pain | Gastrointestinal disorders | Type 2 Diabetes Group: Placebo + Metformin | 8 | 141 | |
| other | Abdominal Pain | Gastrointestinal disorders | Type 2 Diabetes Group: Colesevelam + Metformin | 6 | 141 | |
| other | Abdominal Pain | Gastrointestinal disorders | Pre-diabetic Group: Placebo | 3 | 108 | |
| other | Abdominal Pain | Gastrointestinal disorders | Pre-diabetic Group: Colesevelam | 3 | 107 | |
| other | Abdominal pain uppper | Gastrointestinal disorders | Type 2 Diabetes Group: Placebo + Metformin | 3 | 141 | |
| other | Abdominal pain uppper | Gastrointestinal disorders | Type 2 Diabetes Group: Colesevelam + Metformin | 5 | 141 |
1 to 10 of 164Source ClinicalTrials.gov
See all 164 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Type 2 Diabetes Group: Placebo + Metformin | ||
| Total, all-cause mortality | Type 2 Diabetes Group: Colesevelam + Metformin | ||
| Total, all-cause mortality | Pre-diabetic Group: Placebo | ||
| Total, all-cause mortality | Pre-diabetic Group: Colesevelam | ||
| Total, other adverse events | Type 2 Diabetes Group: Placebo + Metformin | 97 | 141 |
| Total, other adverse events | Type 2 Diabetes Group: Colesevelam + Metformin | 97 | 141 |
| Total, other adverse events | Pre-diabetic Group: Placebo | 63 | 108 |
| Total, other adverse events | Pre-diabetic Group: Colesevelam | 57 | 107 |
| Total, serious adverse events | Type 2 Diabetes Group: Placebo + Metformin | 1 | 141 |
| Total, serious adverse events | Type 2 Diabetes Group: Colesevelam + Metformin | 2 | 145 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers4
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/NCT00570739
GET https://conductscience.org/api/trials/v1/NCT00570739/registered?page=2