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

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ClinicalTrials.gov Identifier: NCT02832999
Recruitment Status : Completed
First Posted : July 14, 2016
Last Update Posted : December 26, 2017
Sponsor:
Collaborators:
University of Yaounde 1
University of Buea
Information provided by (Responsible Party):
Sobngwi Eugene, Yaounde Central Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: sub cutaneous liraglutide Drug: Oral Vildagliptin Phase 4

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : January 2016
Actual Primary Completion Date : September 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy
Drug Information available for: Liraglutide

Arm Intervention/treatment
Experimental: sub cutaneous liraglutide
once daily add-on subcutaneous injection of Liraglutide at 0.6mg/day for 1 week increased to 1.2mg the second week
Drug: sub cutaneous liraglutide
Liraglutide 1.2mg/day
Other Name: Victoza

Active Comparator: Oral Vildagliptin
Once daily oral 100mg of Vildagliptine for two weeks
Drug: Oral Vildagliptin
Vildagliptin 50mg/day
Other Name: Galvus




Primary Outcome Measures :
  1. Insulin sentivity [ Time Frame: 2 weeks ]
    2-week change in clamp-measured insulin sensitivity


Secondary Outcome Measures :
  1. insulin secretion [ Time Frame: 2 weeks ]
    2-week change in meal test measured insulin secretion

  2. lipid profile [ Time Frame: 2 weeks ]
    2-week change in fasting serum lipids

  3. body weight [ Time Frame: 2 weeks ]
    2-week change in body weight


Other Outcome Measures:
  1. Renal function [ Time Frame: 2 weeks ]
    2-week change in serum creatinine

  2. Inflammation [ Time Frame: 2 weeks ]
    2-week change in C-reactive protein



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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT02832999


Locations
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Cameroon
National Obesity Centre
Yaounde, Cameroon
Sponsors and Collaborators
Yaounde Central Hospital
University of Yaounde 1
University of Buea
Investigators
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Principal Investigator: Eugène Sobngwi Yaounde Central Hospital

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Responsible Party: Sobngwi Eugene, Professor of Endocrinology and Diabetes, Yaounde Central Hospital
ClinicalTrials.gov Identifier: NCT02832999     History of Changes
Other Study ID Numbers: CNO20163
First Posted: July 14, 2016    Key Record Dates
Last Update Posted: December 26, 2017
Last Verified: December 2017
Keywords provided by Sobngwi Eugene, Yaounde Central Hospital:
Diabetes
GLP-1
Insulin secretion
insulin sensitivity
Africa
Liraglutide
Vildaglipin
Additional relevant MeSH terms:
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Liraglutide
Diabetes Mellitus
Diabetes Mellitus, Type 2
Insulin Resistance
Hypersensitivity
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Immune System Diseases
Hyperinsulinism
Insulin
Insulin, Globin Zinc
Vildagliptin
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