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Efficacy Evaluation of Different Medication Combination in Type 2 Diabetes Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01076842
Recruitment Status : Completed
First Posted : February 26, 2010
Last Update Posted : June 27, 2011
Sponsor:
Collaborator:
BodyMedia
Information provided by:
Walter Reed Army Medical Center

Tracking Information
First Submitted Date  ICMJE February 25, 2010
First Posted Date  ICMJE February 26, 2010
Last Update Posted Date June 27, 2011
Study Start Date  ICMJE April 2008
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 24, 2011)
The primary endpoint is the improvement in A1C goal measured in mean reduction in A1c levels over 24 weeks. [ Time Frame: 1 month ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 25, 2010)
The primary endpoint is the improvement in A1C goal measured in mean reduction in A1c levels over 24 weeks. [ Time Frame: Jan 2011 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 24, 2011)
Hypoglycemia weight waist-hip ratio frequency of hypoglycemia weight FBGL lipid levels CBC CMP biometric parameters of activity heat flux galvanic skin response heart rate level of physical activity and energy expenditure [ Time Frame: 1 month ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 25, 2010)
Hypoglycemia weight waist-hip ratio frequency of hypoglycemia weight FBGL lipid levels CBC CMP biometric parameters of activity heat flux galvanic skin response heart rate level of physical activity and energy expenditure [ Time Frame: Jan 2011 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy Evaluation of Different Medication Combination in Type 2 Diabetes Treatment
Official Title  ICMJE The Effect of Detemir Compared to Exenatide and/or the Combination of Detemir and Exenatide on Glycemic Control and Weight in Patients With Type 2 Diabetes Mellitus Who Have Failed Oral Hypoglycemic Agents
Brief Summary The purpose of this study is to compare the effectiveness of two different kinds of diabetes medications, insulin detemir (Levemir) and exenatide (Byetta), in improving blood sugar levels with little or no weight gain in patients with type 2 diabetes who are not well controlled on two or more oral (by mouth) diabetes medications. Both medications are given by injection with a very small needle just below the surface of your skin (called subcutaneous injection). The medication that you inject will be in addition to your oral medications.
Detailed Description

Finding a safe and effective method of improving blood glucose (BG) control without weight gain is one of the major goals of diabetes research. Previous research studies have shown that Levemir and Byetta are safe and effective medications in the treatment of type 2 diabetes. Both drugs have been approved by the U.S. Food and Drug Administration (FDA) for the treatment of type 2 diabetes. The use of Levemir and Byetta in combination in this study, is investigational, meaning it is not approved by the FDA for this use. However, the FDA has allowed the use of Levemir and Byetta in combination in this study of safety and effectiveness in improving blood sugar levels with little or no weight gain in people with type 2 diabetes.

Levemir is a long acting insulin that is usually taken once a day at bedtime and can last for up to 24 hours. Unlike most insulins that lower blood glucose levels, but cause weight gain, clinical research trials suggest that Levemir may lower blood glucose levels without causing weight gain and may even result in weight loss.

Byetta is not insulin, but improves blood glucose control by mimicking the action of hormones in the gastrointestinal tract called incretins. The incretin hormones trigger the release of insulin from the pancreas and allow insulin to work more effectively in the body. Byetta also delays the movement of food from the stomach into the small intestine. As a result, people taking Byetta may feel "full" faster and longer, so they eat less. The most common side effect with Byetta is mild to moderate nausea, which improves with time in most people. Clinical research trials that have studied the effects of Byetta have shown that, in addition to lowering blood glucose levels, the use of Byetta resulted in weight loss.

There have been no previous studies that have compared Levemir to Byetta in patients who have failed to achieve blood glucose goals with two or three oral diabetes medications.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Diabetes Type 2
Intervention  ICMJE
  • Drug: Insulin-Levemir
    Levemir once daily, force titrated to reach a fasting plasma glucose of 100 mg/dl
    Other Name: Levemir
  • Drug: Exenatide-Bayetta
    Exenatide twice daily, started at a dose of 5 mcg b.i.d. and increased to 10 mcg b.i.d. after 2 weeks if the fasting plasma glucose of 100 mg/dl is not reached. Exenatide will be administered immediately before breakfast and dinner meals. No further increase in the dose of exenatide will take place. For those who are unable to tolerate exenatide at a 10 mcg b.i.d. dose, it will be reduced to 5 mcg b.i.d. and continued until week 12.
    Other Name: Exenatide
  • Drug: Insulin-Levemir and Exenatide-Bayetta
    Patients from either Group A or Group B who have not reached the goal A1C of 6.5% will be assigned to this Group. They will receive the drug assigned to the other group in addition to the one they were originally assigned.
    Other Name: Levemir+Exenatide
  • Device: SenseWear Pro3® armband
    For one-week prior to beginning the assigned medication and for one week , week 11 and week 23, the patients will wear the SenseWear Pro3® armband for collection of ancillary physiologic data
    Other Name: armband
  • Device: DexCom CGM
    For one-week prior to beginning the assigned medication and for one week , week 11 and week 23, the patients will wear the DexCom CGM for collection of continuous blood glucose concentrations.
    Other Name: continuous glucose monitoring
Study Arms  ICMJE
  • Active Comparator: A Levemir
    Levemir once daily, force titrated to reach a fasting plasma glucose of 100 mg/dl
    Interventions:
    • Drug: Insulin-Levemir
    • Device: SenseWear Pro3® armband
    • Device: DexCom CGM
  • Active Comparator: B Exenatide
    Exenatide twice daily, started at a dose of 5 mcg b.i.d. and increased to 10 mcg b.i.d. after 2 weeks if the fasting plasma glucose of 100 mg/dl is not reached. Exenatide will be administered immediately before breakfast and dinner meals. No further increase in the dose of exenatide will take place. For those who are unable to tolerate exenatide at a 10 mcg b.i.d. dose, it will be reduced to 5 mcg b.i.d. and continued until week 12.
    Interventions:
    • Drug: Exenatide-Bayetta
    • Device: SenseWear Pro3® armband
    • Device: DexCom CGM
  • Active Comparator: C Levemir+Exenatide
    Patients from either Group A or Group B who have not reached the goal A1C of 6.5% will be assigned to this Group. They will receive the drug assigned to the other group in addition to the one they were originally assigned.
    Interventions:
    • Drug: Insulin-Levemir and Exenatide-Bayetta
    • Device: SenseWear Pro3® armband
    • Device: DexCom CGM
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: February 25, 2010)
75
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2011
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. A diagnosis of Type 2 DM for over six months
  2. A history of inadequate glycemic control (A1c > 7.5% but < 10%) despite treatment with 2 or more oral hypoglycemic agents
  3. 18 years of age or older
  4. Stable medical status (e.g., no myocardial infarction, stroke, major surgery, or major mental illness during the previous 6 months)
  5. Naïve to insulin (no insulin for more than 14 days during the previous 6 months and none within 60 days of beginning the study)
  6. On at least ½ maximum or the greatest tolerable dose of their oral agents according to the label for at least 3 months
  7. BMI < 40 kg/m2
  8. Willing to perform at least four finger stick blood glucose measurements each day

Exclusion Criteria:

  1. A diagnosis of Type 2 DM for less than six months
  2. An A1c of < 7.5% or > 10%
  3. Pregnancy as determined by a serum ß HCG.
  4. An unstable medical status
  5. Taking glucocorticoids, amphetamines, anabolic, or weight-reducing agents during the course of the study
  6. Inability to read and write English
  7. Someone who is not likely to return for the follow-up because they or their sponsor is likely to have a permanent change of station or termination of service before completion of the protocol
  8. Unwilling to perform four finger stick blood glucose measurements each day
  9. Previous history of use of exenatide
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01076842
Other Study ID Numbers  ICMJE 08-13028
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Col. Robert A. Vigersky, MD MC, WRAMC- Diabetes Institute
Study Sponsor  ICMJE Novo Nordisk A/S
Collaborators  ICMJE BodyMedia
Investigators  ICMJE
Principal Investigator: Robert A Vigersky, MD WRAMC- Diabetes Institute
PRS Account Walter Reed Army Medical Center
Verification Date June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP