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