Mechanisms of Glucose Lowering Effect of Colesevelam HCl

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Carine Beysen, KineMed
ClinicalTrials.gov Identifier:
NCT00596427
First received: January 8, 2008
Last updated: October 10, 2012
Last verified: October 2012
Results First Received: April 19, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Basic Science
Condition: Diabetes
Interventions: Drug: Colesevelam HCL
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants with type 2 diabetes. All pre-existing drug treatments were stable for at least 3 months prior.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants excluded based on fasting plasma glucose levels, fasting serum triglyceride levels, LDL-cholesterol levels, pregnancy or a history of liver, biliary, or intestinal diseases. Participants treated with insulin or lipid agent less than six months prior were excluded as well.

Reporting Groups
  Description
Type-2 Diabetes Mellitus Patients Treated With Colesevelam Subjects received six tablets a day of colesevelam (3.75g/day) for 12 weeks; three tablets with lunch and three tablets with dinner.
Type-2 Diabetes Mellitus Patients Treated With Placebo Subjects received six tablets a day of matched placebo(3.75g/day) for 12 weeks; three tablets with lunch and three tablets with dinner.

Participant Flow:   Overall Study
    Type-2 Diabetes Mellitus Patients Treated With Colesevelam     Type-2 Diabetes Mellitus Patients Treated With Placebo  
STARTED     30     30  
COMPLETED     26     28  
NOT COMPLETED     4     2  
Withdrawal by Subject                 2                 2  
Increased Fasting Triacylglycerol level                 1                 0  
Protocol Violation                 1                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Type-2 Diabetes Mellitus Patients Treated With Colesevelam Subjects received six tablets a day of colesevelam (3.75g/day) for 12 weeks; three tablets with lunch and three tablets with dinner.
Type-2 Diabetes Mellitus Patients Treated With Placebo Subjects received six tablets a day of matched placebo(3.75g/day) for 12 weeks; three tablets with lunch and three tablets with dinner.
Total Total of all reporting groups

Baseline Measures
    Type-2 Diabetes Mellitus Patients Treated With Colesevelam     Type-2 Diabetes Mellitus Patients Treated With Placebo     Total  
Number of Participants  
[units: participants]
  30     30     60  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     24     25     49  
>=65 years     6     5     11  
Age  
[units: years]
Mean ± Standard Deviation
  59  ± 9     56  ± 9     57.5  ± 9  
Gender  
[units: participants]
     
Female     12     14     26  
Male     18     16     34  
Region of Enrollment  
[units: participants]
     
United States     30     30     60  
BMI [1]
[units: kg/m2]
Mean ± Standard Deviation
  30  ± 5     31  ± 5     30.5  ± 5  
Weight [1]
[units: kg]
Mean ± Standard Deviation
  84  ± 16     88  ± 19     86  ± 18  
HbA 1c  
[units: percentage]
Mean ± Standard Deviation
  8.5  ± 1.2     8.0  ± 0.9     8.25  ± 1.05  
Glucose  
[units: mmol/l]
Mean ± Standard Deviation
  9.2  ± 2.3     8.4  ± 2.4     8.8  ± 2.3  
Insulin  
[units: pmol/l]
Mean ± Standard Deviation
  76  ± 42     97  ± 42     87  ± 42  
Total cholesterol  
[units: mmol/l]
Mean ± Standard Deviation
  4.6  ± 1.2     4.6  ± 1.3     4.6  ± 1.3  
LDL-cholesterol  
[units: mmol/l]
Mean ± Standard Deviation
  2.8  ± 0.8     2.8  ± 1.0     2.8  ± 0.9  
HDL-cholesterol  
[units: mmol/l]
Mean ± Standard Deviation
  0.9  ± 0.2     1.0  ± 0.2     1.0  ± 0.2  
Triacylglycerol  
[units: mmol/l]
Mean ± Standard Deviation
  2.2  ± 0.8     2.0  ± 0.9     2.1  ± 0.9  
[1] Baseline participant characteristics.



  Outcome Measures
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1.  Primary:   Fasting Endogenous Glucose Production (EGP)   [ Time Frame: baseline and 12 weeks ]

2.  Primary:   Fasting Gluconeogenesis   [ Time Frame: baseline and 12 weeks ]

3.  Primary:   Fasting Glycogenolysis   [ Time Frame: baseline and 12 weeks ]

4.  Primary:   Rate of Appearance of Exogenous Glucose (Glucose Absorption)   [ Time Frame: baseline and 12 weeks ]

5.  Secondary:   Total Glucagon-like Peptide (GLP-1) Area Under the Curve (AUC)   [ Time Frame: baseline and 12 weeks ]

6.  Secondary:   Total Glucose-dependent Insulinotropic Polypeptide (GIP) AUC   [ Time Frame: baseline and 12 weeks ]

7.  Secondary:   Fasting Fractional De Novo Lipogenesis (DNL)   [ Time Frame: baseline and 12 weeks ]

8.  Secondary:   Fasting Fractional Cholesterol Synthesis   [ Time Frame: baseline and 12 weeks ]

9.  Secondary:   Postprandial Fractional Cholic Acid Synthesis   [ Time Frame: baseline and 12 weeks ]

10.  Secondary:   Glucagon AUC   [ Time Frame: baseline and 12 weeks ]

11.  Other Pre-specified:   Glycosylated Hemoglobin (HbAlc)   [ Time Frame: baseline and 12 weeks ]

12.  Other Pre-specified:   Glucose AUC   [ Time Frame: baseline and 12 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Carine Beysen, PhD
Organization: Kinemed, Inc
phone: 5106556525 ext 123
e-mail: cbeysen@kinemed.com


Publications:
Publications automatically indexed to this study:

Responsible Party: Carine Beysen, KineMed
ClinicalTrials.gov Identifier: NCT00596427     History of Changes
Other Study ID Numbers: KM-11A
Study First Received: January 8, 2008
Results First Received: April 19, 2012
Last Updated: October 10, 2012
Health Authority: United States: Institutional Review Board