| Trial ID: | L6966 |
| Source ID: | NCT00411411
|
| Associated Drug: |
Januvia
|
| Title: |
Long Term Effects of DPP-IV Inhibitor Treatment in Patients With Type 2 Diabetes
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00411411/results
|
| Conditions: |
Type 2 Diabetes
|
| Interventions: |
DRUG: Januvia|DRUG: Placebo
|
| Outcome Measures: |
Primary: the Relative Increase in Meal-induced Total GLP-1 Secretion, 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)., 12 weeks|Restoration of the Insulinotropic Effect of GIP, 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., 12 weeks | Secondary: Examination of GLP-2, Somatostatin, Glucagon, Peptide-YY and Two Glycaemic Control Parameters (HbA1c and Fasting Plasma Glucose), 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, 12 weeks
|
| Sponsor/Collaborators: |
Sponsor: University Hospital, Gentofte, Copenhagen | Collaborators: Merck Sharp & Dohme LLC
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
49
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2007-02
|
| Completion Date: |
2009-03
|
| Results First Posted: |
2014-08-13
|
| Last Update Posted: |
2014-08-13
|
| Locations: |
Gentofte Hospital, Hellerup, 2900, Denmark
|
| URL: |
https://clinicaltrials.gov/show/NCT00411411
|
