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Trial record 38 of 7512 for:    Type 2 Diabetes

Effect of Linagliptin on Insulin Sensitivity and Pancreatic Beta Cell Function in Patients With Type 2 Diabetes Mellitus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02097342
Recruitment Status : Unknown
Verified April 2014 by Anil Bhansali, Postgraduate Institute of Medical Education and Research.
Recruitment status was:  Recruiting
First Posted : March 27, 2014
Last Update Posted : April 8, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Insulin Sensitivity/Resistance Drug: Linagliptin Drug: Placebo Drug: Voglibose Phase 4

Detailed Description:

This is a prospective study of 30 patients with type 2 diabetes mellitus (T2DM) . Patients with T2DM in the age group 30-65 years and duration of diabetes less than five years will be screened. After exclusion, those who meet the inclusion criteria will be included in the study.

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : December 2013
Estimated Primary Completion Date : November 2014
Estimated Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy
Drug Information available for: Linagliptin
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Linagliptin
Tablet Linagliptin (5mg) per oral, once daily will be given to 10 patients for 6 months
Drug: Linagliptin
Tablet Linagliptin (5mg) per oral, once daily will be given to 10 patients for 6 months
Other Name: Trajenta 5mg
Placebo Comparator: Placebo
Tablet Placebo per oral, once daily will be given to 10 patients for 6 months
Drug: Placebo
Tablet placebo per oral, once daily will be given to 10 patients for 6 months
Active Comparator: Voglibose
Tablet Voglibose (0.2mg) per oral, thrice daily (with meals) will be given to 10 patients for 6 months
Drug: Voglibose
Tablet Voglibose (0.2mg) per oral thrice daily(with meals) to 10 patients for 6 months


Outcome Measures

Primary Outcome Measures :
  1. To study the effect of Linagliptin on insulin sensitivity by performing euglycemic hyperinsulinemic clamp in patients with type 2 diabetes mellitus. [ Time Frame: 6 months ]

    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)



Secondary Outcome Measures :
  1. To study the effects of Linagliptin on glycemic control and beta cell function in patients with type 2 diabetes mellitus 6 months [ Time Frame: 6 months ]

    Fasting and 2 hour postprandial blood glucose will be at baseline and after 6 months of treatment. HbA1C will be done at baseline and after 3 and 6 months.

    HOMA-IR and HOMA-β will be done at baseline and after 6 months. Patients will also be subjected to a mixed meal test at baseline and at 6 months. Mixed meal test will be done 3-7 days after clamp study. After an overnight fast of 10 hours, patients will be given standardized mixed meal, 2.5 g/ kg. (Ensure, Abbott Nutrition, Abbott Laboratories) Medications normally taken by the subject in the morning will be administered 20 min prior to the start of the test meal. Samples for glucose, insulin, C-peptide and glucagon-like peptide-1 (GLP-1) will be taken at 0,30,60,90,120,150 and 180 minutes following the ingestion of meal. Total area under curves for glucose, insulin, C-peptide and GLP-1 from pre meal to 180 min will be calculated using the trapezoidal rule.



Other Outcome Measures:
  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 [ Time Frame: 6 months ]
    Patients will be subjected to mixed meal test and a hyperinsulinemic euglycemic clamp study at baseline and after 6 months of treatment.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02097342


Contacts
Contact: Anil Bhansali, MD DM 01722756580 anilbhansaliendocrine@gmail.com
Contact: Girish Parthan, MD 8872375221 girishparthan@gmail.com

Locations
India
Postgraduate Institute of Medical Education & Research Recruiting
Chandigarh, India, 160012
Contact: Anil Bhansali, MD DM       anilbhansaliendocrine@gmail.com   
Sponsors and Collaborators
Postgraduate Institute of Medical Education and Research
More Information

Responsible Party: Anil Bhansali, Professor, Department of Endocrinology, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier: NCT02097342     History of Changes
Other Study ID Numbers: Linagliptin
First Posted: March 27, 2014    Key Record Dates
Last Update Posted: April 8, 2014
Last Verified: April 2014

Keywords provided by Anil Bhansali, Postgraduate Institute of Medical Education and Research:
Type 2 Diabetes Mellitus
Insulin sensitivity- hyperinsulinemic euglycemic clamp
Pancreatic beta cell function
Linagliptin
Voglibose
Mixed meal test
GLP-1 response

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Hypersensitivity
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Immune System Diseases
Hyperinsulinism
Voglibose
Insulin
Linagliptin
Inositol
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Glycoside Hydrolase Inhibitors
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances