Effect of Linagliptin on Insulin Sensitivity and Pancreatic Beta Cell Function in Patients With Type 2 Diabetes Mellitus
NCT ID: NCT02097342
Last Updated: 2014-04-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
30 participants
INTERVENTIONAL
2013-12-31
2015-01-31
Brief Summary
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Detailed Description
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Once eligibility criteria are confirmed, patients will be educated about their disease and will be advised weight maintenance diabetic diet and exercise throughout the study period. Patients will be randomized to three groups - linagliptin (5mg OD) or voglibose (0.2mg TDS) or placebo OD. Metformin will be continued in all patients. To evaluate the effect of linagliptin on insulin sensitivity and beta cell function, independent of changes in HbA1c, the voglibose group is included. Each group will have 10 patients and will be followed up for 6 months. Both patients and physicians will be blinded to the treatment.
After having written informed consent, a detailed history and a thorough clinical examination will be done in all subjects including measurement of height, weight, body mass index and waist circumference. Hemoglobin, liver function tests, renal function tests, lipid profile, HbA1c, fasting plasma insulin , C-peptide, homeostasis model assessment-insulin resistance index(HOMA-1R) and homeostasis model assessment-beta cell function index (HOMA-β) will be done at baseline. A euglycemic hyperinsulinemic clamp study and a mixed meal test will be performed in all patients (on different days) at baseline and after 6 months of follow up. Biochemical parameters will be measured again 6 months after therapy. Fasting and post-prandial blood glucose will be done monthly for 6 months.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Linagliptin
Tablet Linagliptin (5mg) per oral, once daily will be given to 10 patients for 6 months
Linagliptin
Tablet Linagliptin (5mg) per oral, once daily will be given to 10 patients for 6 months
Placebo
Tablet Placebo per oral, once daily will be given to 10 patients for 6 months
Placebo
Tablet placebo per oral, once daily will be given to 10 patients for 6 months
Voglibose
Tablet Voglibose (0.2mg) per oral, thrice daily (with meals) will be given to 10 patients for 6 months
Voglibose
Tablet Voglibose (0.2mg) per oral thrice daily(with meals) to 10 patients for 6 months
Interventions
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Linagliptin
Tablet Linagliptin (5mg) per oral, once daily will be given to 10 patients for 6 months
Placebo
Tablet placebo per oral, once daily will be given to 10 patients for 6 months
Voglibose
Tablet Voglibose (0.2mg) per oral thrice daily(with meals) to 10 patients for 6 months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age between 30-65 years
* Duration of diabetes less than five years
* BMI of between 20 and 40 kg/m2
* HbA1c level of \< 7.5%
* On metformin monotherapy for at least 6 weeks
Exclusion Criteria
* Hepatic impairment (defined as plasma aminotransferase elevations of more than 3 times upper limit of normal)
* Renal failure (defined as Serum Creatinine more than 1.5 mg/dl)
* Coronary artery disease or heart failure
* Cerebrovascular disease or stroke
* Anemia (Hb\< 10 g/dl)
* Those who requires insulin therapy HbA1c \>7.5%
* Presence of macular edema
* Pregnant or lactating women
* Patients who have received dipeptidyl peptidase 4 (DPP-4) inhibitor therapy within last 3 months
30 Years
65 Years
ALL
No
Sponsors
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Post Graduate Institute of Medical Education and Research, Chandigarh
OTHER
Responsible Party
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Anil Bhansali
Professor, Department of Endocrinology
Locations
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Postgraduate Institute of Medical Education & Research
Chandigarh, Chandigarh, India
Countries
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Central Contacts
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Facility Contacts
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References
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Parthan G, Bhansali S, Kurpad AV, Walia R, Bhat K, Bhansali A. Effect of Linagliptin and Voglibose on metabolic profile in patients with Type 2 Diabetes: a randomized, double-blind, placebo-controlled trial. BMC Pharmacol Toxicol. 2018 Jul 3;19(1):38. doi: 10.1186/s40360-018-0228-z.
Other Identifiers
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Linagliptin
Identifier Type: -
Identifier Source: org_study_id
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