| Trial ID: | L4689 |
| Source ID: | NCT02725502
|
| Associated Drug: |
Linagliptin
|
| Title: |
Incretin Axis in Type 1 Diabetes Mellitus
|
| Acronym: |
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 1 Diabetes Mellitus
|
| Interventions: |
DRUG: Linagliptin|DRUG: Placebo
|
| Outcome Measures: |
Primary: Effect of Linagliptin on HbA1c in T1DM patients, Change in HbA1C in linagliptin group as compared to placebo group, After 3 months of the starting of the treatment|Effect of Linagliptin on glycemic variability in T1DM patients, Change in glycemic variability (CGMS indices) in linagliptin group as compared to placebo group, After 3 months of the starting of the treatment|Effect of Linagliptin on insulin requirement in T1DM patients, Change in insulin requirement in linagliptin group as compared to placebo group, After 3 months of the starting of the treatment | Secondary: Effect of linagliptin on GLP1 level during mixed meal test in T1DM patients, Change in Area under the curve (AUC) of GLP1 during mixed meal test in linagliptin group as compared to placebo group, after 3 months of the starting of the treatment|Effect of linagliptin on glucagon level during mixed meal test in T1DM patients, Change in Area under the curve (AUC) of glucagon during mixed meal test in linagliptin group as compared to placebo group, after 3 months of the starting of the treatment
|
| Sponsor/Collaborators: |
Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh
|
| Gender: |
ALL
|
| Age: |
CHILD, ADULT
|
| Phases: |
|
| Enrollment: |
20
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2013-07
|
| Completion Date: |
2016-05
|
| Results First Posted: |
|
| Last Update Posted: |
2016-04-01
|
| Locations: |
Department of Endocrinology, PGIMER, Chandigarh, 160012, India
|
| URL: |
https://clinicaltrials.gov/show/NCT02725502
|
