Trial Outcomes & Findings for Long Term Effects of DPP-IV Inhibitor Treatment in Patients With Type 2 Diabetes (NCT NCT00411411)
NCT ID: NCT00411411
Last Updated: 2014-08-13
Results Overview
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).
COMPLETED
PHASE3
49 participants
12 weeks
2014-08-13
Participant Flow
Patients recruited from Jan. 2008 to Dec 2009 through out-patient clinic and advertisement
Participant milestones
| Measure |
Placebo
Placebo treatment
|
Januvia
Active treatment
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
25
|
|
Overall Study
COMPLETED
|
24
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Long Term Effects of DPP-IV Inhibitor Treatment in Patients With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Placebo
n=24 Participants
Placebo treatment
|
Januvia
n=25 Participants
Active treatment
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
60 years
n=5 Participants
|
60 years
n=7 Participants
|
60 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Region of Enrollment
Denmark
|
24 participants
n=5 Participants
|
25 participants
n=7 Participants
|
49 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPatients 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).
Outcome measures
| Measure |
Placebo
n=12 Participants
Placebo: Placebo
|
Januvia
n=12 Participants
Active treatment
Januvia: 200 mg t.i.d
|
|---|---|---|
|
the Relative Increase in Meal-induced Total GLP-1 Secretion
|
2591 pM x 120 min
Standard Deviation 358
|
3959 pM x 120 min
Standard Deviation 877
|
PRIMARY outcome
Timeframe: 12 weeksRestoration 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.
Outcome measures
| Measure |
Placebo
n=12 Participants
Placebo: Placebo
|
Januvia
n=13 Participants
Active treatment
Januvia: 200 mg t.i.d
|
|---|---|---|
|
Restoration of the Insulinotropic Effect of GIP
After 1 week
|
17.8 pM x 120 min
Standard Error 3.0
|
21.3 pM x 120 min
Standard Error 4.3
|
|
Restoration of the Insulinotropic Effect of GIP
After 12 weeks
|
19.7 pM x 120 min
Standard Error 3.7
|
30.0 pM x 120 min
Standard Error 6.2
|
SECONDARY outcome
Timeframe: 12 weeksSecondary 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
Outcome measures
Outcome data not reported
Adverse Events
Placebo
Januvia
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60