Short Term Effect of Liraglutide Versus Vildagliptine on Insulin Secretion and Insulin Sensitivity in Type 2 Diabetes

Type 2 Diabetes Mellitus Clinical Trial

— LIRAVIS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02832999
• Other study ID #: CNO20163
• Status: Completed
• Phase: Phase 4
• First received: July 12, 2016
• Last updated: December 21, 2017
• Start date: January 2016
• Est. completion date: December 2016

Study information

• Verified date: December 2017
• Source: Yaounde Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Hypersensitivity
• Insulin Resistance
• Type 2 Diabetes Mellitus

Intervention

Drug:
• sub cutaneous liraglutide
Liraglutide 1.2mg/day
• Oral Vildagliptin
Vildagliptin 50mg/day

Locations

Country	Name	City	State
Cameroon	National Obesity Centre	Yaounde

Sponsors (3)

Lead Sponsor	Collaborator
Yaounde Central Hospital	University of Buea, University of Yaounde 1

Country where clinical trial is conducted

Cameroon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Renal function	2-week change in serum creatinine	2 weeks
Other	Inflammation	2-week change in C-reactive protein	2 weeks
Primary	Insulin sentivity	2-week change in clamp-measured insulin sensitivity	2 weeks
Secondary	insulin secretion	2-week change in meal test measured insulin secretion	2 weeks
Secondary	lipid profile	2-week change in fasting serum lipids	2 weeks
Secondary	body weight	2-week change in body weight	2 weeks