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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.
No text entered.

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 
Overall Participants Analyzed 
[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) 
[1] Baseline participant characteristics.
Weight [1] 
[Units: Kg]
Mean (Standard Deviation)
 84  (16)   88  (19)   86  (18) 
[1] Baseline participant characteristics.
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) 


  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 by ClinicalTrials.gov Identifier (NCT Number):

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