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Long Term Effects of DPP-IV Inhibitor Treatment in Patients With Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT00411411
Recruitment Status : Completed
First Posted : December 14, 2006
Results First Posted : August 13, 2014
Last Update Posted : August 13, 2014
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Kasper Aaboe, University Hospital, Gentofte, Copenhagen

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Type 2 Diabetes
Interventions Drug: Januvia
Drug: Placebo
Enrollment 49
Recruitment Details Patients recruited from Jan. 2008 to Dec 2009 through out-patient clinic and advertisement
Pre-assignment Details  
Arm/Group Title Placebo Januvia
Hide Arm/Group Description Placebo treatment Active treatment
Period Title: Overall Study
Started 24 25
Completed 24 25
Not Completed 0 0
Arm/Group Title Placebo Januvia Total
Hide Arm/Group Description Placebo treatment Active treatment Total of all reporting groups
Overall Number of Baseline Participants 24 25 49
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 25 participants 49 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
23
  95.8%
25
 100.0%
48
  98.0%
>=65 years
1
   4.2%
0
   0.0%
1
   2.0%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 24 participants 25 participants 49 participants
60
(31 to 72)
60
(39 to 64)
60
(31 to 72)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 25 participants 49 participants
Female
11
  45.8%
12
  48.0%
23
  46.9%
Male
13
  54.2%
13
  52.0%
26
  53.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Denmark Number Analyzed 24 participants 25 participants 49 participants
24 25 49
1.Primary Outcome
Title the Relative Increase in Meal-induced Total GLP-1 Secretion
Hide Description Patients will be followed for 12 weeks with three meal test examinations; before treatment, after 1 week of treatment and after 12 weeks of treatment. Primary outcome is AUC GLP-1 (pM x 120 as stated).
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Januvia
Hide Arm/Group Description:
Placebo: Placebo

Active treatment

Januvia: 200 mg t.i.d

Overall Number of Participants Analyzed 12 12
Mean (Standard Deviation)
Unit of Measure: pM x 120 min
2591  (358) 3959  (877)
2.Primary Outcome
Title Restoration of the Insulinotropic Effect of GIP
Hide Description Restoration of the insulinotropic effect of GIP measured as the relative increase in GIP induced amplification of the late phase insulin secretion (AUC) response to glucose. Patients will be followed for 12 weeks with examinations after 1 and after 12 weeks of treatment.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Januvia
Hide Arm/Group Description:

Placebo treatment, administered as tablets.

Placebo: Placebo

Active treatment

Januvia: 200 mg t.i.d

Overall Number of Participants Analyzed 12 13
Mean (Standard Error)
Unit of Measure: pM x 120 min
After 1 week 17.8  (3.0) 21.3  (4.3)
After 12 weeks 19.7  (3.7) 30.0  (6.2)
3.Secondary Outcome
Title Examination of GLP-2, Somatostatin, Glucagon, Peptide-YY and Two Glycaemic Control Parameters (HbA1c and Fasting Plasma Glucose)
Hide Description Secondary objectives are examination of GLP-2, somatostatin, glucagon, peptide-YY and two glycaemic control parameters (HbA1c and fasting plasma glucose). Patients will be followed for 12 weeks with three examinations; before, during and after the treatment
Time Frame 12 weeks
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Januvia
Hide Arm/Group Description No adverse events recorded Active treatment. No adverse events recorded
All-Cause Mortality
Placebo Januvia
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Januvia
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Placebo Januvia
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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
Name/Title: Dr. Kasper Aaboe
Organization: Gentofte University Hospital
Phone: +4522170200
Responsible Party: Kasper Aaboe, University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier: NCT00411411     History of Changes
Other Study ID Numbers: 1502
First Submitted: December 13, 2006
First Posted: December 14, 2006
Results First Submitted: May 19, 2014
Results First Posted: August 13, 2014
Last Update Posted: August 13, 2014