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This study is designed to assess the potential mechanism of action by which WelChol® (colesevelam) may improve blood glucose control in patients with type 2 diabetes
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | colesevelam 3.8g administered daily for 12 weeks |
|
| 2 | Placebo Comparator | Colesevelam matching placebo for 12 weeks |
|
| 3 | Active Comparator | open-label Insulin Glargine for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colesevelam | Drug | Colesevelam 3.8g for 12 weeks |
| |
| Colesevelam matching placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in Endogenous (Hepatic) Glucose Output During a High-dose Insulin Infusion From Baseline to After 12 Weeks of Treatment. | The parameter measured is the endogenous (hepatic) glucose output during a high-dose insulin infusion. A decrease after treatment with colesevelam is indicative of greater sensitivity of the liver to insulin. | Baseline to 12 weeks |
| Difference in Endogenous (Hepatic) Glucose Output During a Low-dose Insulin Infusion From Baseline to Week 12. | The parameter measured is the endogenous (hepatic) glucose output during a low-dose insulin infusion. A decrease is indicative of greater senstitivity of the liver to insulin. | Baseline to 12 weeks |
| Acute Effect of a Single Dose of Colesevelam on Oral Glucose Absorption From Baseline to First Dose | Change in area under the curve for glucose (AUCg) after a glucose tolerance test. A decrease in AUCg is indicative of a drug effect. | Baseline (Day -4) to first dose (Day 1) |
| Measure | Description | Time Frame |
|---|---|---|
| The Acute Effect of Colesevelam (Multiple Doses) on Oral Glucose Absorption From Baseline to 12 Weeks | The parameter measured is the change in area under the curve for glucose(AUCg) after an oral glucose tolerance test. A decrease in AUCg indicative of drug effect on glucose absorption. | Baseline to 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Diego VMC | San Diego | California | 92161 | United States |
Subjects were taken off any non-sulfonylurea oral anti-diabetic agents for a period of time appropriate to the drug. Qualified subjects were randomized to colesevelam hydrochloride, placebo, or open-label insulin glargine for 12 weeks. Difficulties enrolling into the insulin group caused the size of this group to decrease from 15 to 6 subjects.
Subjects were recruited from 21 June 2005 to 22 January 2008 at 3 clinical research sites in the United States of America.
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| ID | Title | Description |
|---|---|---|
| FG000 | Colesevelam 3.8g | colesevelam 3.8g administered daily for 12 weeks |
| FG001 | Colesevelam Matching Placebo | Colesevelam matching placebo for 12 weeks |
| FG002 | Open-label Insulin Glargine | open-label Insulin Glargine for 12 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Colesevelam 3.8g | colesevelam 3.8g administered daily for 12 weeks |
| BG001 | Colesevelam Matching Placebo | Colesevelam matching placebo for 12 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Difference in Endogenous (Hepatic) Glucose Output During a High-dose Insulin Infusion From Baseline to After 12 Weeks of Treatment. | The parameter measured is the endogenous (hepatic) glucose output during a high-dose insulin infusion. A decrease after treatment with colesevelam is indicative of greater sensitivity of the liver to insulin. | The population analyzed was all randomized subjects who received medication and had a baseline and at least 1 post-randomization assessment of an efficacy variable. One placebo participant did not have a valid post-randomization insulin clamp study. Therefore, the number included in the placebo group for this analysis was 13. | Posted | Least Squares Mean | Standard Error | mg/kg/min | Baseline to 12 weeks |
|
12 week treatment period plus 30 days after the last dose of study medication.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Colesevelam 3.8g | colesevelam 3.8g administered daily for 12 weeks |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ventricular extrasystoles | Cardiac disorders | MedDRA (9.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John Raia, Senior Director, Professional Affairs | Daiichi Sankyo, Inc | (973) 944-2683 | jraia@dsi.com |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069472 | Colesevelam Hydrochloride |
| D000069036 | Insulin Glargine |
| ID | Term |
|---|---|
| D000499 | Allylamine |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D000498 | Allyl Compounds |
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| Drug |
Colesevelam matching placebo for 12 weeks |
|
| Insulin glargine (Lantus) | Drug | Insulin glargine for 12 weeks |
|
| Change in Hemoglobin A1C Due to Effect of Colesevelam From Baseline to 12 Weeks |
The parameter measured is the percent of hemoglobin A that is glycosylated. A decrease in this parameter is indicative of improved glucose control. |
| Baseline to 12 weeks |
| BG002 | Open-label Insulin Glargine | open-label Insulin Glargine for 12 weeks |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass | Mean | Full Range | kg/m2 |
|
| Fasting Plasma Glucose | Mean | Full Range | mg/dL |
|
| HbA1c | Mean | Full Range | percent |
|
| Height | Mean | Full Range | cm |
|
| Weight | Mean | Full Range | kg |
|
| OG001 | Colesevelam Matching Placebo | Colesevelam matching placebo for 12 weeks |
| OG002 | Open-label Insulin Glargine | open-label Insulin Glargine for 12 weeks |
|
|
|
| Primary | Difference in Endogenous (Hepatic) Glucose Output During a Low-dose Insulin Infusion From Baseline to Week 12. | The parameter measured is the endogenous (hepatic) glucose output during a low-dose insulin infusion. A decrease is indicative of greater senstitivity of the liver to insulin. | The population analyzed was all randomized subjects who received medication and had a baseline and at least 1 post-randomization assessment of an efficacy variable. One placebo participant did not have a valid post-randomization insulin clamp study. Therefore, the number included in the placebo group for this analysis was 13. | Posted | Least Squares Mean | Standard Error | mg/kg/min | Baseline to 12 weeks |
|
|
|
|
| Secondary | The Acute Effect of Colesevelam (Multiple Doses) on Oral Glucose Absorption From Baseline to 12 Weeks | The parameter measured is the change in area under the curve for glucose(AUCg) after an oral glucose tolerance test. A decrease in AUCg indicative of drug effect on glucose absorption. | One participant in the colesevelam 3.8g group discontinued. Therefore, 15 participants were included in this analysis. | Posted | Least Squares Mean | Standard Error | mg*hr/dL | Baseline to 12 weeks |
|
|
|
|
| Secondary | Change in Hemoglobin A1C Due to Effect of Colesevelam From Baseline to 12 Weeks | The parameter measured is the percent of hemoglobin A that is glycosylated. A decrease in this parameter is indicative of improved glucose control. | One participant in the colesevelam 3.8g group discontinued. Therefore, 15 participants were included in this analysis. The least squares mean is adjusted for baseline values. This corrects for differences in baseline values between treatment groups. | Posted | Least Squares Mean | Standard Error | percent | Baseline to 12 weeks |
|
|
|
|
| Primary | Acute Effect of a Single Dose of Colesevelam on Oral Glucose Absorption From Baseline to First Dose | Change in area under the curve for glucose (AUCg) after a glucose tolerance test. A decrease in AUCg is indicative of a drug effect. | The entire study population was included in this analysis | Posted | Mean | Standard Deviation | mg*hr/dL | Baseline (Day -4) to first dose (Day 1) |
|
|
|
|
| 0 |
| 16 |
| 14 |
| 16 |
| EG001 | Colesevelam Matching Placebo | Colesevelam matching placebo for 12 weeks | 0 | 14 | 10 | 14 |
| EG002 | Open-label Insulin Glargine | open-label Insulin Glargine for 12 weeks | 0 | 6 | 4 | 6 |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
|
| Diarrhea NOS | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
|
| Gastroesophageal Reflux disease | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
|
| Vomiting NOS | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
|
| Infusion site pain | General disorders | MedDRA (9.0) | Systematic Assessment |
|
| Oedema | General disorders | MedDRA (9.0) | Systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA (9.0) | Systematic Assessment |
|
| Ear Infection NOS | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
|
| Tooth Abcess | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
|
| Vaginosis Fungal NOS | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
|
| Viral Infection NOS | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
|
| Heat exhaustion | Injury, poisoning and procedural complications | MedDRA (9.0) | Systematic Assessment |
|
| Electrocardiogram QT prolonged | Investigations | MedDRA (9.0) | Systematic Assessment |
|
| Elecrtocariogram ST Segment Depression | Investigations | MedDRA (9.0) | Systematic Assessment |
|
| Electrocardiogram T Wave Abnormal | Investigations | MedDRA (9.0) | Systematic Assessment |
|
| Electrocardiogram T Wave Inversion | Investigations | MedDRA (9.0) | Systematic Assessment |
|
| Heart Rate Increased | Investigations | MedDRA (9.0) | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Systematic Assessment |
|
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
|
| Migraine NOS | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
|
| Dysmenorrhea | Reproductive system and breast disorders | MedDRA (9.0) | Systematic Assessment |
|
| Erectile Dysfunction NOS | Reproductive system and breast disorders | MedDRA (9.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
|
| Pharyngolaryngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
|
| Sinus Pain | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
|
If identified by Daiichi Sankyo, Inc. (DSI), any of DSI's confidential information as defined herein shall be deleted…Nothing in this publication section shall be taken as giving DSI any right of editorial control over any publication prepared by Study Site.
| D004700 | Endocrine System Diseases |
| D000475 |
| Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| Mean Difference (Final Values) |
| -0.03 |
| Standard Error of the Mean |
| 0.083 |
| 95 |
| -0.20 |
| 0.14 |
| No |
| Superiority or Other |
| ANCOVA | 0.1727 | Mean Difference (Final Values) | 0.12 | Standard Error of the Mean | 0.085 | 95 | -0.05 | 0.29 | No | Superiority or Other |
| Mean Difference (Final Values) |
| 10.1 |
| Standard Error of the Mean |
| 69.98 |
| 95 |
| -132.6 |
| 152.9 |
| No |
| Superiority or Other |
| ANCOVA | 0.4226 | Mean Difference (Final Values) | -54.5 | Standard Error of the Mean | 67.08 | 95 | -191.3 | 82.3 | No | Superiority or Other |
| Mean Difference (Final Values) |
| 0.52 |
| Standard Error of the Mean |
| 0.515 |
| 95 |
| -0.53 |
| 1.57 |
| No |
| Superiority or Other |
| ANCOVA | 0.0613 | Mean Difference (Final Values) | -0.97 | Standard Error of the Mean | 0.500 | 95 | -1.99 | 0.05 | No | Superiority or Other |