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Clinical Trial NCT01076842 for Diabetes Type 2 is completed. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Novo Nordisk A/SEfficacy Evaluation of Different Medication Combination in Type 2 Diabetes Treatment Phase 4 75
Clinical Trial NCT01076842 was designed to study Treatment for Diabetes Type 2. This was a Phase 4 interventional study that is now completed. The study started on 1 April 2008, with plans to enroll 75 participants. Led by Novo Nordisk A/S, the expected completion date was 1 April 2011. The latest data from ClinicalTrials.gov was last updated on 27 June 2011.
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 ...Show More
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 Byett...Show More
Official Title
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
Conditions
Diabetes Type 2Other Study IDs
- 08-13028
NCT ID Number
Start Date (Actual)
2008-04
Last Update Posted
2011-06-27
Completion Date (Estimated)
2011-04
Enrollment (Estimated)
75
Study Type
Interventional
PHASE
Phase 4
Status
Completed
Keywords
Diabetes
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Active ComparatorA Levemir Levemir once daily, force titrated to reach a fasting plasma glucose of 100 mg/dl | Insulin-Levemir Levemir once daily, force titrated to reach a fasting plasma glucose of 100 mg/dl 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 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. |
Active ComparatorB 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 continue...Show More | 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 continue...Show More 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 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. |
Active ComparatorC 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. | 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. 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 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. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
The primary endpoint is the improvement in A1C goal measured in mean reduction in A1c levels over 24 weeks. | 1 month |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 | 1 month |
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- A diagnosis of Type 2 DM for over six months
- A history of inadequate glycemic control (A1c > 7.5% but < 10%) despite treatment with 2 or more oral hypoglycemic agents
- 18 years of age or older
- Stable medical status (e.g., no myocardial infarction, stroke, major surgery, or major mental illness during the previous 6 months)
- Naïve to insulin (no insulin for more than 14 days during the previous 6 months and none within 60 days of beginning the study)
- On at least ½ maximum or the greatest tolerable dose of their oral agents according to the label for at least 3 months
- BMI < 40 kg/m2
- Willing to perform at least four finger stick blood glucose measurements each day
- A diagnosis of Type 2 DM for less than six months
- An A1c of < 7.5% or > 10%
- Pregnancy as determined by a serum ß HCG.
- An unstable medical status
- Taking glucocorticoids, amphetamines, anabolic, or weight-reducing agents during the course of the study
- Inability to read and write English
- 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
- Unwilling to perform four finger stick blood glucose measurements each day
- Previous history of use of exenatide
Novo Nordisk A/S131 active studies to exploreBodyMediaNo contact data.
2 Study Locations in 1 Countries
District of Columbia
MedStar Research Institute, Washington D.C., District of Columbia, 20003, United States
Walter Reed Army Medical Center, Washington D.C., District of Columbia, 20306, United States