Effect of Linagliptin on Insulin Sensitivity and Pancreatic Beta Cell Function in Patients With Type 2 Diabetes Mellitus
A Randomized Double-blind Study to Evaluate the Effect of Linagliptin on Pancreatic Beta Cell Function and Insulin Sensitivity in Patients With Type 2 Diabetes Mellitus on Metformin Monotherapy
1 other identifier
interventional
30
1 country
1
Brief Summary
This study is planned to evaluate if linagliptin can improve insulin sensitivity in patients with type 2 diabetes mellitus. In addition, the effect of linagliptin on pancreatic function will be studied.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 type-2-diabetes-mellitus
Started Dec 2013
Shorter than P25 for phase_4 type-2-diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2013
CompletedFirst Submitted
Initial submission to the registry
March 24, 2014
CompletedFirst Posted
Study publicly available on registry
March 27, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedApril 8, 2014
April 1, 2014
11 months
March 24, 2014
April 6, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To study the effect of Linagliptin on insulin sensitivity by performing euglycemic hyperinsulinemic clamp in patients with type 2 diabetes mellitus.
Hyperinsulinemic euglycemic clamp of 2 hours duration will be done at baseline and after 6 months of treatment in all patients. Medications taken by the patient will be omitted on the day of test.After an overnight fast of 10 hours, intravenous catheter will be inserted, under sterile precautions, into the antecubital vein for infusion of insulin and dextrose solutions, while another catheter will be inserted in an anti-flow direction into the dorsal vein of the contralateral hand for arterialized blood sampling. An insulin infusate of 300 mU/ml will be administered at a constant rate, after an initial priming dose, while a 25 percent dextrose solution is administered at varying rates to maintain blood glucose at 90 mg/dl. Blood glucose will be analyzed by a bedside glucose analyzer every 5 minutes. M value, a measure of glucose utilisation will be calculated during the steady state (last 30 minutes of the test)
6 months
Secondary Outcomes (1)
To study the effects of Linagliptin on glycemic control and beta cell function in patients with type 2 diabetes mellitus 6 months
6 months
Other Outcomes (1)
To study the effect of voglibose on glucagon like peptide1 (GLP1) secretion and insulin resistance in patients with type 2 diabetes mellitus 6 months
6 months
Study Arms (3)
Linagliptin
EXPERIMENTALTablet Linagliptin (5mg) per oral, once daily will be given to 10 patients for 6 months
Placebo
PLACEBO COMPARATORTablet Placebo per oral, once daily will be given to 10 patients for 6 months
Voglibose
ACTIVE COMPARATORTablet Voglibose (0.2mg) per oral, thrice daily (with meals) will be given to 10 patients for 6 months
Interventions
Tablet Linagliptin (5mg) per oral, once daily will be given to 10 patients for 6 months
Tablet Voglibose (0.2mg) per oral thrice daily(with meals) to 10 patients for 6 months
Eligibility Criteria
You may qualify if:
- Patients with type 2 diabetes mellitus (according to ADA guidelines)
- 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
You may not qualify if:
- History of ketoacidosis
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Postgraduate Institute of Medical Education & Research
Chandigarh, Chandigarh, 160012, India
Related Publications (1)
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.
PMID: 29970184DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Department of Endocrinology
Study Record Dates
First Submitted
March 24, 2014
First Posted
March 27, 2014
Study Start
December 1, 2013
Primary Completion
November 1, 2014
Study Completion
January 1, 2015
Last Updated
April 8, 2014
Record last verified: 2014-04