- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01381926
Changes in Bone Turnover With Exposure to a GLP-1 Receptor Agonist (CMBD)
Changes in Bone Turnover With Exposure to a GLP-1 Receptor Agonist (UAB Core Center for Basic Skeletal Research)
The purpose of this study is to determine changes in bone turnover markers and calcitonin following the initiation of exenatide compared to placebo in postmenopausal women wtih type 2 diabetes.
Hypothesis 1a: Bone resorption (measured by osteocalcin and bone-specific alkaline phosphatase) will be lower and bone formation (measured by type I collagen crosslinked aminoterminal peptide in urine (Urine NTX)) will be higher when subjects are treated with exenatide compared to when subjects are treated with placebo.
Hypothesis 1b: Calcitonin levels will not vary significantly between periods of treatment with exenatide vs. placebo.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35294
- University of Alabama at Birmingham
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Postmenopausal women (as defined by age ≥45 years old or amenorrhea for >2years)
- Type 2 DM currently not on diabetes-specific medication(s) or treated with monotherapy of metformin or a sulfonylurea. Patients treated with insulin monotherapy will also be eligible if the total daily dose of insulin is ≤10units. If on a medication for diabetes prior to study entry, the medication can be discontinued for 2 weeks prior to study initiation.
- Hemoglobin A1c (HbA1c) of 6.5-9.0%
Exclusion Criteria:
- Use of an incretin mimetic (i.e. exenatide, liraglutide), a DPP-4 inhibitor (i.e. sitagliptin, saxagliptin), a thiazolidinedione, or oral glucocorticoids in the 6 months prior to the study will not be eligible
- Known osteoporosis or patients treated with an osteoporosis-specific medication (bisphosphonate, teriparatide) or estrogen (including Selective Estrogen Receptor Modulators (SERMs)) or those who anticipate imminent treatment with one of these medications will be excluded from the study
- Chronic kidney disease (calculated GFR <30 ml/min) or a disease known to affect bone turnover (i.e. Paget Disease, Osteogenesis Imperfecta, HIV) will be excluded from the study.
- History of pancreatitis
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Exenatide then Placebo
Study participants in phase1 will receive the study drug, exenatide, at a dose of 5mg subcutaneously twice daily 30 minutes before meals for one month.
During the second month of the study, the dose of exenatide will be increased to 10mg subcutaneously twice daily before meals for one month.
During the third month of the study, no study medication will be given and this will serve as a "wash out" period prior to the second phase of the study (placebo).
During the fourth and fifth months, study participants will get placebo alternatives to exenatide 5mg and exenatide 10mg, respectively, subcutaneously twice daily before meals.
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exenatide 5mcg sq twice daily for one month and exenatide 10mcg twice daily for month 2. The 3rd month is a washout period.
Month 4 and 5 saline placebo is given as 5mcg and 10mcg respectively.
Other Names:
Month 1 and 2 saline placebo is given as a low and high dose respectively.
The 3rd month is a washout period.
Month 4 exenatide 5mcg sq twice daily and for month 5 exenatide 10mcg twice daily is administered.
Other Names:
|
Active Comparator: Placebo then Exenatide
Study participants in phase1 will receive the saline placebo, at a dose of 5mcg subcutaneously twice daily 30 minutes before meals for one month.
During the second month of the study, the saline placebo will be increased to 10mcg subcutaneously twice daily before meals for one month.
During the third month of the study, no treatment will be given and this will serve as a "wash out" period prior to the second phase of the study.
During the fourth month study participants will receive Exenatide 5mcg twice daily with meals.
During the fifth month, study participants will receive exenatide 10mcg, subcutaneously twice daily before meals.
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exenatide 5mcg sq twice daily for one month and exenatide 10mcg twice daily for month 2. The 3rd month is a washout period.
Month 4 and 5 saline placebo is given as 5mcg and 10mcg respectively.
Other Names:
Month 1 and 2 saline placebo is given as a low and high dose respectively.
The 3rd month is a washout period.
Month 4 exenatide 5mcg sq twice daily and for month 5 exenatide 10mcg twice daily is administered.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Determine Changes in Bone Resorption Markers During the Treatment With a GLP-1 Receptor Agonist (Exenatide) Compared to Placebo in Patients With T2DM.
Time Frame: Baseline to 20 weeks
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Bone reabsorption by bone-specific alkaline phosphatase (BAP) was assessed.
Distribution of the Difference between EX/PBO Low/High Dose and Baseline Levels were calculated.
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Baseline to 20 weeks
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Determine Changes in Bone Turnover Markers by Serum N-Telo Peptide During the Treatment With a GLP-1 Receptor Agonist (Exenatide) Compared to Placebo in Patients With T2DM.
Time Frame: Baseline to 20 weeks
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Bone turnover by Serum N-Telo peptide (NTX) was assessed.
Distribution of the Difference between EX/PBO Low/High Dose and Baseline Levels were calculated
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Baseline to 20 weeks
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Determine Changes in Bone Turnover Markers by Tartrate-Resistant Acid Phosphatase 5b (TRACP5b) During the Treatment With a GLP-1 Receptor Agonist (Exenatide) Compared to Placebo in Patients With T2DM.
Time Frame: Baseline to 20 weeks
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Bone turnover by Tartrate-Resistant Acid Phosphatase 5b (TRACP5b) was assessed.
Distribution of the Difference between EX/PBO Low/High Dose and Baseline Levels were calculated.
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Baseline to 20 weeks
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Amy Warriner, MD, University of Alabama at Birmingham
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- F100929001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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