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| Name | Class |
|---|---|
| International Diabetes Center at Park Nicollet | OTHER |
| Daiichi Sankyo | INDUSTRY |
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The purpose of this study is to obtain continuous glucose monitoring (CGM) data from individuals taking Welchol compared to placebo. The CGM data will determine the effect on glucose control of adding Welchol to an anti-diabetic medication regimen.
To understand the effect of the addition of colesevelam HCl to oral agent therapy in individuals with type 2 diabetes on glycemic control by utilizing a novel technology, continuous glucose monitoring with ambulatory glucose profile analysis. To date there are no studies of this compound that have employed continuous glucose monitoring (CGM) with ambulatory glucose profile (AGP) analysis to obtain data that will detail the diurnal glucose patterns associated with this therapy. We plan to employ CGM at critical points throughout the study. AGP analysis will enable rapid assessment of the clinical status of the subject. Using statistically stable estimates of hourly values represented by five percentile curves AGP depicts glucose exposure, variability and stability. Previously, we have used AGP analysis to characterize glucose perturbations in individuals ranging from normal glucose tolerance to overt type 2 diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Welchol then Placebo | Placebo Comparator | 3.75 grams of colesevelam HCl (Welchol) at evening meal for 12 weeks, and then crossover to placebo at evening meal for 12 weeks. |
|
| Placebo then Welchol | Placebo Comparator | Placebo taken for 12 weeks at evening meal, and then crossover to 3.75 grams of colesevelam HCl taken at evening meal fro 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| colesevelam HCl | Drug | 3.75 grams of colesevelam HCl (6 tablets) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Norm AUC Average by Group (Normalized) | Double Blinded CGM used for 2 week periods at the start of treatment 1, end of treatment 1, start of treatment 2, and end of treatment 2. | 2 week periods at the start of treatment 1, end of treatment 1, start of treatment 2, and end of treatment 2. |
| Sleep Norm AUC Average by Group (Normalized) | Overnight glucose captured by CGM. | 2 week periods at the start of treatment 1, end of treatment 1, start of treatment 2, and end of treatment 2. |
| Wake Norm AUC Average by Group (Normalized) | Wake glucose captured by continuous glucose monitoring (CGM). | 2 week periods at the start of treatment 1, end of treatment 1, start of treatment 2, and end of treatment 2. |
| Hypoglycemia Percentage of Time <70 mg/dL Average by Group | Ambulatory glucose profile (AGP) reports were examined for the changes in the incidence of hypoglycemia (CGM<70 mg/dL) | 2 week periods at the start of treatment 1, end of treatment 1, start of treatment 2, and end of treatment 2. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roger S. Mazze, PhD | International Diabetes Center at Park Nicollet | Study Director |
| Elinor S. Strock, APRN, BC | International Diabetes Center at Park Nicollet | Principal Investigator |
| Robert M. Cuddihy, MD | International Diabetes Center at Park Nicollet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| International Diabetes Center | Minneapolis | Minnesota | 55416 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18852398 | Result | Bays HE, Goldberg RB, Truitt KE, Jones MR. Colesevelam hydrochloride therapy in patients with type 2 diabetes mellitus treated with metformin: glucose and lipid effects. Arch Intern Med. 2008 Oct 13;168(18):1975-83. doi: 10.1001/archinte.168.18.1975. | |
| 18473688 | Result | Mazze RS, Strock E, Wesley D, Borgman S, Morgan B, Bergenstal R, Cuddihy R. Characterizing glucose exposure for individuals with normal glucose tolerance using continuous glucose monitoring and ambulatory glucose profile analysis. Diabetes Technol Ther. 2008 Jun;10(3):149-59. doi: 10.1089/dia.2007.0293. |
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Recruitment Jan 2010 to Mar 2011. Medical Clinic Setting.
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| ID | Title | Description |
|---|---|---|
| FG000 | Welchol Then Placebo | 3.75 grams of colesevelam HCl (Welchol) taken for 12 weeks at evening meal, and then crossover to placebo taken at evening meal fro 12 weeks. |
| FG001 | Placebo Then Welchol | Placebo taken for 12 weeks at evening meal, and then crossover to 3.75 grams of colesevelam HCl taken at evening meal for 12 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Welchol Then Placebo | 3.75 grams of colesevelam HCl taken at evening meal for 12 weeks, then crossover to placebo taken at evening meal for 12 weeks. |
| BG001 | Placebo Then Welchol |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Total Norm AUC Average by Group (Normalized) | Double Blinded CGM used for 2 week periods at the start of treatment 1, end of treatment 1, start of treatment 2, and end of treatment 2. | Posted | Mean | Standard Deviation | mg/(dL/hr) normalized | 2 week periods at the start of treatment 1, end of treatment 1, start of treatment 2, and end of treatment 2. |
|
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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 | Welchol | 3.75 grams of colesevelam HCl taken at evening meal |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Roger Mazze PhD | International Diabetes Center | 952-993-3796 | rmazze@aol.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 |
| ID | Term |
|---|---|
| D000499 | Allylamine |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D000498 | Allyl Compounds |
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| placebo | Drug |
|
| 18663165 | Result | Goldberg RB, Fonseca VA, Truitt KE, Jones MR. Efficacy and safety of colesevelam in patients with type 2 diabetes mellitus and inadequate glycemic control receiving insulin-based therapy. Arch Intern Med. 2008 Jul 28;168(14):1531-40. doi: 10.1001/archinte.168.14.1531. |
| 19132850 | Result | Mazze RS, Strock E, Borgman S, Wesley D, Stout P, Racchini J. Evaluating the accuracy, reliability, and clinical applicability of continuous glucose monitoring (CGM): Is CGM ready for real time? Diabetes Technol Ther. 2009 Jan;11(1):11-8. doi: 10.1089/dia.2008.0041. |
| 17379048 | Result | Zieve FJ, Kalin MF, Schwartz SL, Jones MR, Bailey WL. Results of the glucose-lowering effect of WelChol study (GLOWS): a randomized, double-blind, placebo-controlled pilot study evaluating the effect of colesevelam hydrochloride on glycemic control in subjects with type 2 diabetes. Clin Ther. 2007 Jan;29(1):74-83. doi: 10.1016/j.clinthera.2007.01.003. |
Placebo taken at evening meal for 12 weeks, then crossover to 3.75 grams of colesevelam HCl taken at evening meal for 12 weeks.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Total norm AUC average | Total norm HbA1c AUC was assessed by the CGM. The baseline CGM period started 14 days before randomization (visit 1) and concluded at randomization (visit 2). The data was then normalized. | Mean | Standard Deviation | mg/(dL/hr) (normalized) |
|
| Sleep norm Area under the curve average by group | Sleep norm HbA1c AUC was assessed by the CGM. The baseline CGM period started 14 days before randomization (visit 1) and concluded at randomization (visit 2). The data was then normalized. | Mean | Standard Deviation | mg/(dL/hr) (normalized) |
|
| Wake norm area under the curve average by group | Wake norm HbA1c AUC was assessed by the CGM. The baseline CGM period started 14 days before randomization (visit 1) and concluded at randomization (visit 2). The data was then normalized. | Mean | Standard Deviation | mg/(dL/hr) (normalized) |
|
| Hypoglycemia percentage of time <70 mg/dL average by group | Hypoglycemia percentage of time <70 mg/dL average by group was assessed by the CGM. The baseline CGM period started 14 days before randomization (visit 1) and concluded at randomization (visit 2). | Mean | Standard Deviation | percentage of time <70 mg/dL |
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| Primary | Sleep Norm AUC Average by Group (Normalized) | Overnight glucose captured by CGM. | Posted | Mean | Standard Deviation | mg/(dL/hr) normalized | 2 week periods at the start of treatment 1, end of treatment 1, start of treatment 2, and end of treatment 2. |
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| Primary | Wake Norm AUC Average by Group (Normalized) | Wake glucose captured by continuous glucose monitoring (CGM). | Posted | Mean | Standard Deviation | mg/(dL/hr) (normalized) | 2 week periods at the start of treatment 1, end of treatment 1, start of treatment 2, and end of treatment 2. |
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| Primary | Hypoglycemia Percentage of Time <70 mg/dL Average by Group | Ambulatory glucose profile (AGP) reports were examined for the changes in the incidence of hypoglycemia (CGM<70 mg/dL) | Posted | Mean | Standard Deviation | percentage of time <70 mg/dL | 2 week periods at the start of treatment 1, end of treatment 1, start of treatment 2, and end of treatment 2. |
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| 0 |
| 21 |
| 0 |
| 21 |
| EG001 | Placebo | Placebo taken at evening meal | 0 | 21 | 0 | 21 |
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| D004700 | Endocrine System Diseases |
| D000475 |
| Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| Start of Treatment 2 |
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| End of Treatment 2 |
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| Start of Treatment 2 |
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| End of Treatment 2 |
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| Start of Treatment 2 |
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| End of Treatment 2 |
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