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Efficacy Evaluation of Different Medication Combination in Type 2 Diabetes Treatment
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
Lead sponsor
Asset
Exenatide
GLP-1 agonist
Listed sites
2
Recruiting sites
—
Enrollment
75
estimated
Study population
Type 2 diabetes
Key I/E criteria
•BMI ≤40•HbA1c ≥7.5%
Primary endpoint
•HbA1c, change
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
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
Endpoints (2)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Glycemic / diabetes
1 endpointThe primary endpoint is the improvement in A1C goal measured in mean reduction in A1c levels over 24 weeks.
Time frame:1 month
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Other (unclassified)
1 endpointHypoglycemia 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
descriptive
componentsDocumented hypoglycemia, Body weight, absolute change (kg), Waist circumference, change, Fasting glucose, change, Triglycerides, change, Total cholesterol, change, HDL-C, change, LDL-C, change, Heart rate, change
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.