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OpenTrials
Completed

NCT Number: NCT00484419

Effects of Colesevelam HCl, Rosiglitazone, Sitagliptin on Control of Blood Glucose and Lipids in Type 2 Diabetes Patients Whose Blood Glucose Isn't Completely Controlled With Metformin

A 16 week open-label study with subjects receiving background metformin monotherapy. 150 subjects randomized 1:1:1 to receive 1 of the following: open-label colesevelam HCl, open label rosiglitazone, or open-label sitagliptin.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Dyslipidemias Endocrine System Diseases Glucose Metabolism Disorders Hyperlipidemia Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

La Mesa, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • HbA1C 7.0 % to 10.0% on metformin monotherapy; may be withdrawn from other (non-metformin) drugs if HbA1C is 6.5% to 9.5 % at screening.

Exclusion criteria

  • Subjects currently treated with a thiazolidinedione are excluded.

Treatment and study plan

Colesevelam HCl

Drug

coleveselam tablets 625 mg; 6 tablets/day

rosiglitazone maleate

Drug

rosiglitazone tablets 4mg

sitagliptin phosphate

Drug

sitagliptin phosphate tablets 100mg/day

Primary outcomes

  1. Mean Percentage of Change in HbA1c From Week 0(Baseline) to Week 16 Endpoint

    Time frame: 16 weeks change = week 16 - week 0.

    Change in HbA1c from Week 0(baseline) to Week 16 endpoint mean with standard deviation change = week 16 - week 0.

Secondary outcomes

  1. Mean Percentage of Change in Glycosylated Hemoglobin (HbA1c) From Week 0(Baseline) to Week 16 Endpoint Least Squares Mean

    Time frame: 16 weeks change = week 16 - week 0.

    Change in HbA1c from Week 0(baseline)to Week 16 endpoint least squares mean with 95% confidence intervals, change = week 16 - week 0.

  2. Mean Percentage of Change in HbA1c From Week 0(Baseline) to Week 8

    Time frame: 8 weeks change = week 8- week 0.

    change in HbA1c from Week 0(baseline) to week 8 mean and standard deviation change = week 8 - week 0.

  3. Change in Fasting Plasma Glucose (FPG) From Week 0(Baseline) to Week 8 Least Squares Mean

    Time frame: 8 weeks change = week 8- week 0.

    change in FPG from Week 0(baseline) to week 8 least squares mean and 95% confidence interval change = week 8 - week 0.

  4. Change in FPG From Week 0(Baseline) to Week 16 Least Squares Mean

    Time frame: 16 weeks change = week 16 - week 0.

    change in FPG from Week 0(baseline) to week 16 least squares mean and 95% confidence interval change = week 16 - week 0.

  5. Mean Change in FPG From Week 0(Baseline) to Week 8

    Time frame: 8 weeks change = week 8- week 0.

    mean change in FPG from Week 0(baseline) to Week 8 with standard deviation change = week 8 - week 0.

  6. Mean Change in FPG From Week 0(Baseline) to Week 16

    Time frame: 16 weeks change = week 16 - week 0.

    change in FPG from Week 0(baseline) to week 16 mean and standard deviation change = week 16 - week 0.

  7. Change in Fasting Insulin From Week 0(Baseline) to Week 8 Least Squares Mean

    Time frame: 8 weeks change = week 8- week 0.

    change in fasting insulin from Week 0(baseline) to week 8 least squares mean and 95% confidence interval change = week 8 - week 0.

  8. Change in Fasting Insulin From Week 0(Baseline) to Week 16 Least Squares Mean

    Time frame: 16 weeks change = week 16 - week 0.

    change in fasting insulin from Week 0(baseline) to week 16 least squares mean and 95% confidence interval change = week 16 - week 0.

  9. Mean Change in Fasting Insulin From Week 0(Baseline) to Week 8

    Time frame: 8 weeks change = week 8- week 0.

    mean change in fasting insulin from Week 0(baseline) to week 8 with standard deviation change = week 8 - week 0.

  10. Mean Change in Fasting Insulin From Week 0(Baseline) to Week 16

    Time frame: 16 weeks change = week 16 - week 0.

    mean change in fasting insulin from Week 0(baseline) to week 16 with standard deviation change = week 16 - week 0.

  11. Change in Post-prandial Glucose From Week 0(Baseline) to Week 16 Least Squares Mean

    Time frame: 16 weeks change = week 16 - week 0.

    change in post-prandial glucose from Week 0(baseline) to week 16 least squares mean with 95% confidence intervals change = week 16 - week 0.

  12. Mean Change in Post-prandial Glucose From Week 0(Baseline) to Week 16

    Time frame: 16 weeks change = week 16 - week 0.

    mean change in post-prandial glucose from Week 0(baseline) to week 16 with standard deviation change = week 16 - week 0.

  13. Mean Change in Post-prandial Insulin From Week 0(Baseline) to Week 16

    Time frame: 16 weeks change = week 16 - week 0.

    mean change in post-prandial insulin from Week 0(baseline) to week 16 with standard deviation change = week 16 - week 0.

  14. Change in Low-Density Lipoprotein-C(LDL-C) From Week 0(Baseline) to Week 16 Least Squares Mean

    Time frame: 16 weeks change = week 16 - week 0.

    change in LDL-C from Week 0(baseline) to week 16 least squares mean with 95% confidence intervals change = week 16 - week 0.

  15. Mean Change in LDL-C From Week 0(Baseline) to Week 16

    Time frame: 16 weeks change = week 16 - week 0.

    mean change in LDL-C from Week 0(baseline) to week 16 with standard deviation change = week 16 - week 0.

  16. Mean Percentage of Change in LDL-C Levels From Week 0(Baseline) to Week 16

    Time frame: 16 weeks change = week 16 - week 0.

    mean percent change in LDL-C levels from Week 0(baseline) to Week 16 mean with standard deviation change = week 16 - week 0.

  17. Mean Percentage of Change in LDL-C Levels From Week 0(Baseline) to Week 16 (Least Squares Mean)

    Time frame: 16 weeks change = week 16 - week 0.

    percent change in LDL-C levels from Week 0(baseline) to Week 16 (least squares mean with 95% confidence interval)

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo

Industry

Registry information

Official study title

Effects of Colesevelam HCl, Avandia® (Rosiglitazone Maleate), or JanuviaTM (Sitagliptin) on Glycemic Parameters and Lipid Profiles in Subjects With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin Monotherapy

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jun 8, 2007
Registry last updated
Oct 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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