Overview

Incretin Axis in Type 1 Diabetes Mellitus

Status:
Unknown status
Trial end date:
2016-05-01
Target enrollment:
0
Participant gender:
All
Summary
Type 1 diabetes is an autoimmune disorder characterized by beta cell destruction resulting in insulinopenia. Currently it is being treated with insulin. Dipeptidylpeptidase inhibitors (DPP4 inhibitors e.g. linagliptin & sitagliptin) has been used for type 2 diabetes mellitus (T2DM) traditionally. Previous studies has shown that it is also effective in type 1 diabetes mellitus (T1DM), but the mechanism of action not well understood. This study will evaluate possible mechanism of action of linagliptin in T1DM patients.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Postgraduate Institute of Medical Education and Research
Treatments:
Incretins
Insulin
Insulin, Globin Zinc
Linagliptin
Criteria
Inclusion Criteria:

- Male or female adult, aged 15 to 30 years

- Duration of type 1 Diabetes Mellitus for 6 months or more, as established by medical
history

- Current treatment with multiple injections of insulin for at least 3 months prior to
screening visit; and using the same insulin during the last 1 month

- HbA1c < 8%

- Body mass index (BMI) < 25 kg/mt2

- Euthyroid patient. If thyroid dysfunction is present then thyroid function test (TFT)
should be normal at the time of study ( with medication)

Exclusion Criteria:

- On pramlintide, metformin, GLP1 agonist or DPP4 inhibitor. If taking this drugs then
stop them 2 wk prior to study.

- On prokinetics & proton pump inhibitor (PPI). If taking this drugs then stop them 2 wk
prior to study

- Creatinine of >1.5 mg/dl or a calculated creatinin clearance of <50 ml/min or overt
proteinuria.

- Fasting blood glucose (FBG) < 72 or > 180 in the day of mixed meal test (MMT)

- Pregnant

- Seriously ill patients

- Presence of gastroparesis ( if history is suggestive of autonomic neuropathy or
gastroparesis then gastric emptying study to be done to rule it out)

- Type 1 Diabetes Mellitus for less than 6 months duration

- Presence of celiac disease