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CompletedPhase 4

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

Novo Nordisk A/S

Asset

Exenatide

GLP-1 agonist

Listed sites

2

Recruiting sites

Enrollment

75

estimated

Study population

Type 2 diabetes

Key I/E criteria

BMI ≤40HbA1c ≥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

NCT IDNCT01076842
Org study ID08-13028

Timeline

Milestones

Study first posted2010-02-26estimated
Last update posted2011-06-27estimated
Study start2008-04 (month precision)
Primary completion2011-04actual (month precision)
Study completion2011-04actual (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age90 Years
SexAll
Healthy volunteersNot accepted

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
Other (unclassified)
1

Glycemic / diabetes

1 endpoint
Primary/protocol endpoint

The 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 endpoint
Secondary/protocol endpoint/low confidence

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

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 identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

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.