Trial | NCT02832999  Report issue

Title

Short Term Effect of Liraglutide Versus Vildagliptine on Insulin Secretion and Insulin Sensitivity in Type 2 Diabetes
Short Term Effect of Liraglutide Versus Vildagliptine on Insulin Secretion and Insulin Sensitivity in a Sub Saharan African Population With Type 2 Diabetes

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    14
This is a single blind randomised controlled clinical trial in uncontrolled type 2 Diabetes mellitus patients on oral glucose lowering agents, and naive to incretinomimetic. Participants will be randomised in two Arms : arm 1 receiving Liraglutide at 1,2 mg/day and arm 2 Vildagliptine at 100mg/day over 14 days. The two arms will be compared for 14-day changes in insulin secretion and insulin sensitivity.
Incretinomimetics include exogenous Glucagon-Like Peptide analogs (GLP1a) such as Liraglutide, and inhibitors of Dipeptidyl peptidase IV (DPP4i) that prolong the half-life of endogenous GLP1 such as Vildagliptin. It remains unclear which of the two strategies (exogenous GLP1 or prolonging half-life of endogenous GLP1) have better short term effect on insulin sensitivity and insulin secretion in people living with type 2 diabetes.

This study aims to investigate the short-term metabolic effects of a GLP-1 analog Liraglutide versus a DPP4i Vildagliptin. It is a randomized, controlled, single-blinded clinical trial. Study population consists of uncontrolled type 2 diabetes mellitus patients (HbA1c≥7%) under mono or bi oral anti-diabetic therapy, naïve of any incretinomimetic treatment. Participants are randomized in 2 arms. The intervention in arm 1 consists of add-on subcutaneous Liraglutide at 0.6mg/day for 1 week increased to 1.2mg the second week. In the second arm, it consists of oral Vildagliptine at 100mg daily for two weeks. The primary outcome is the variation in euglycaemic hyperinsulinaemic clamp-derived insulin sensitivity before randomization and the day after intervention, secondary outcomes include 14-day changes in insulin secretion during a mixed meal tolarance test, body weight and body composition, and an indirect calorimetry measured resting energy expenditure. Changes from baseline to 14 days in serum creatinine and alanine amino transferase, C-reactive protein and lipid profile will also be recorded.
Study Started
Jan 31
2016
Primary Completion
Sep 30
2016
Study Completion
Dec 31
2016
Last Update
Dec 26
2017

Drug sub cutaneous liraglutide

Liraglutide 1.2mg/day

  • Other names: Victoza

Drug Oral Vildagliptin

Vildagliptin 50mg/day

  • Other names: Galvus

sub cutaneous liraglutide Experimental

once daily add-on subcutaneous injection of Liraglutide at 0.6mg/day for 1 week increased to 1.2mg the second week

Oral Vildagliptin Active Comparator

Once daily oral 100mg of Vildagliptine for two weeks

Criteria 

Inclusion Criteria:

Type 2 diabetes mellitus known for at least one year
Uncontrolled glycaemic profile with HbA1c ≥ 7% on oral antidiabetic mono or bi-therapy
Naïve of incretinomimetic treatment
Informed consent

Exclusion Criteria:

Change in antidiabetic treatment less than 3 months prior to inclusion
Pancreatitis
Alanine amino transferase > 3 times the normal values
Pregnant or breastfeeding women
Estimated glomerular filtration rate < 60ml/min
Infection less than 10 days prior to inclusion or during the study
Acute complication of diabetes
Total haemoglobin < 11g/dL in women or < 13g/dL in men
Withdrawal of consent
No Results Posted