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Trial record 70 of 231 for:    CALCITONIN SALMON

Changes in Bone Turnover With Exposure to a GLP-1 Receptor Agonist (CMBD)

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ClinicalTrials.gov Identifier: NCT01381926
Recruitment Status : Terminated (unavailability of study drug and matching placebo)
First Posted : June 27, 2011
Results First Posted : June 14, 2017
Last Update Posted : June 14, 2017
Sponsor:
Collaborator:
Amylin Pharmaceuticals, LLC.
Information provided by (Responsible Party):
Amy H. Warriner, University of Alabama at Birmingham

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Type 2 Diabetes Mellitus
Bone Remodeling
Interventions Drug: exenatide
Drug: Saline
Enrollment 14
Recruitment Details Protocol open to accrual: February 2011, primary completion date, August 2015 and study completion date August 2015. Recruitment location at UAB. Postmenopausal women with diabetes mellitus on no medications or metformin alone were recruited from a single outpatient clinic setting.
Pre-assignment Details Potential participants attended a screening visit to ensure they met inclusion/exclusion criteria. If they were on metformin at the screening visit, it was discontinued. They returned in 1 month for the baseline visit and randomization.
Arm/Group Title Exenatide 1st Then Placebo Placebo 1st Then Exenatide
Hide Arm/Group Description Study participants in period 1 will receive the study drug, exenatide, at a dose of 5mcg 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 10mcg 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 period of the study (placebo). During the fourth and fifth months, study participants will get placebo alternatives to exenatide 5mcg and exenatide 10mcg, respectively, subcutaneously twice daily before meals. Study participants in periods1 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 dose of 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 periods of the study. During the fourth month participants will receive Exenatide 5mcg twice daily before meals. During the fifth month, study participants will get Exenatide 10mcg twice daily before meals.
Period Title: Low/High Dose of 1st Treatment (2months)
Started [1] 5 5
Completed 3 4
Not Completed 2 1
Reason Not Completed
Adverse Event             2             0
Withdrawal by Subject             0             1
[1]
The number of participants started is for each segment. Crossover study. Total is not applicable.
Period Title: Low/High Dose of 2nd Treatment (2months)
Started 3 4
Completed 3 4
Not Completed 0 0
Arm/Group Title Placebo 1st Then Exenatide Exenatide 1st Then Placebo Total
Hide Arm/Group Description Study participants in period1 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 dose of 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 periods of the study. During the fourth month participants will receive Exenatide 5mcg twice daily before meals. During the fifth month, study participants will get Exenatide 10mcg twice daily before meals. Study participants in period 1 will receive the study drug, exenatide, at a dose of 5mcg 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 10mcg 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 period of the study (placebo). During the fourth and fifth months, study participants will get placebo alternatives to exenatide 5mcg and exenatide 10mcg, respectively, subcutaneously twice daily before meals. Total of all reporting groups
Overall Number of Baseline Participants 5 5 10
Hide Baseline Analysis Population Description
This is a crossover study. Not all patients completed both arms of the study. 14 patients were screened. 10 presented for the baseline study and were provided some study medication. 1 participant's specimen was not analyzed and she is not included in analysis for that reason. 5 started Exenatide; 5 started Placebo.
Age, Continuous  
Median (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5 participants 5 participants 10 participants
61  (4.2) 61  (3.8) 61  (4.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 5 participants 10 participants
Female
5
 100.0%
5
 100.0%
10
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 5 participants 10 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
  40.0%
2
  40.0%
4
  40.0%
White
3
  60.0%
3
  60.0%
6
  60.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 5 participants 5 participants 10 participants
5 5 10
1.Primary Outcome
Title Determine Changes in Bone Resorption Markers During the Treatment With a GLP-1 Receptor Agonist (Exenatide) Compared to Placebo in Patients With T2DM.
Hide Description 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.
Time Frame Baseline to 20 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
For Crossover study, participants were matched for the placebo and study drug arms. As such, only data from participants completing both arms were included in the statistical analysis.
Arm/Group Title Exenatide 1st Then Placebo Placebo 1st Then Exenatide
Hide Arm/Group Description:
Study participants in phase1 will receive the study drug, exenatide, at a dose of 5mcg 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 10mcg 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 5mcg and exenatide 10mcg, respectively, subcutaneously twice daily before meals.
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 dose of 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 participants will receive Exenatide 5mcg twice daily before meals. During the fifth month, study participants will get Exenatide 10mcg twice daily before meals.
Overall Number of Participants Analyzed 3 4
Mean (Standard Deviation)
Unit of Measure: mg/L
1.925  (1.6) -0.20  (3.34)
2.Primary Outcome
Title 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.
Hide Description 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
Time Frame Baseline to 20 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
For Crossover, study, participants were matched for the placebo and study drug arms. As such, only data from participants completing both arms were included in the statistical analysis.
Arm/Group Title Exenatide Then Placebo Placebo Then Exenatide
Hide Arm/Group Description:

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.

exenatide: 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.

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.

exenatide: 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.

Overall Number of Participants Analyzed 3 4
Mean (Standard Deviation)
Unit of Measure: nMBCE/L
-0.8  (2.31) 1.725  (2.72)
3.Primary Outcome
Title 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.
Hide Description 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.
Time Frame Baseline to 20 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
For Crossover, study, participants were matched for the placebo and study drug arms. As such, only data from participants completing both arms were included in the statistical analysis.
Arm/Group Title Exenatide 1st Then Placebo Placebo 1st Then Exenatide
Hide Arm/Group Description:
Study participants in phase1 will receive the study drug, exenatide, at a dose of 5mcg 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 10mcg 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 5mcg and exenatide 10mcg, respectively, subcutaneously twice daily before meals.
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 dose of 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 participants will receive Exenatide 5mcg twice daily before meals. During the fifth month, study participants will get Exenatide 10mcg twice daily before meals.
Overall Number of Participants Analyzed 3 4
Mean (Standard Deviation)
Unit of Measure: U/L
0.05  (0.80) 0.325  (0.59)
Time Frame Baseline to 20 weeks
Adverse Event Reporting Description clinicaltrials.gov definitions used
 
Arm/Group Title Exenatide 1st Then Placebo Placebo 1st Then Exenatide
Hide Arm/Group Description Study participants in phase1 will receive the study drug, exenatide, at a dose of 5mcg 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 10mcg 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 5mcg and exenatide 10mcg, respectively, subcutaneously twice daily before meals. 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 dose of 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 participants will receive Exenatide 5mcg twice daily before meals. During the fifth month, study participants will get Exenatide 10mcg twice daily before meals.
All-Cause Mortality
Exenatide 1st Then Placebo Placebo 1st Then Exenatide
Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)      0/4 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Exenatide 1st Then Placebo Placebo 1st Then Exenatide
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/3 (0.00%)      0/4 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Exenatide 1st Then Placebo Placebo 1st Then Exenatide
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/3 (66.67%)      0/4 (0.00%)    
Gastrointestinal disorders     
Nausea/vomiting (1st treatment period)   1/3 (33.33%)  1 0/4 (0.00%)  0
Skin and subcutaneous tissue disorders     
Pruritis (2nd treatment period)   1/3 (33.33%)  1 0/4 (0.00%)  0
Indicates events were collected by systematic assessment
Study was closed due to unavailability of study drug/matching placebo prior to recruitment of target participants. The original drug company was bought and new company was unwilling to supply medication. Small participant number limits data analysis.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Amy Warriner
Organization: UAB
Phone: 205-996-4004
EMail: awarriner@uabmc.edu
Layout table for additonal information
Responsible Party: Amy H. Warriner, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01381926     History of Changes
Other Study ID Numbers: F100929001
First Submitted: June 13, 2011
First Posted: June 27, 2011
Results First Submitted: January 14, 2017
Results First Posted: June 14, 2017
Last Update Posted: June 14, 2017