NCT02832999

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_4 type-2-diabetes-mellitus

Timeline
Completed

Started Jan 2016

Shorter than P25 for phase_4 type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 12, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 14, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

December 26, 2017

Status Verified

December 1, 2017

Enrollment Period

8 months

First QC Date

July 12, 2016

Last Update Submit

December 21, 2017

Conditions

Type 2 Diabetes Mellitus

Keywords

DiabetesGLP-1Insulin secretioninsulin sensitivityAfricaLiraglutideVildaglipin

Outcome Measures

Primary Outcomes (1)

  • Insulin sentivity

    2-week change in clamp-measured insulin sensitivity

    2 weeks

Secondary Outcomes (3)

  • insulin secretion

    2 weeks

  • lipid profile

    2 weeks

  • body weight

    2 weeks

Other Outcomes (2)

  • Renal function

    2 weeks

  • Inflammation

    2 weeks

Study Arms (2)

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

Drug: sub cutaneous liraglutide

Oral Vildagliptin

ACTIVE COMPARATOR

Once daily oral 100mg of Vildagliptine for two weeks

Drug: Oral Vildagliptin

Interventions

sub cutaneous liraglutideDRUG

Liraglutide 1.2mg/day

Also known as: Victoza
sub cutaneous liraglutide
Oral VildagliptinDRUG

Vildagliptin 50mg/day

Also known as: Galvus
Oral Vildagliptin

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Pancreatitis
  • Alanine amino transferase \> 3 times the normal values
  • Pregnant or breastfeeding women
  • Estimated glomerular filtration rate \< 60ml/min
  • Acute complication of diabetes
  • Total haemoglobin \< 11g/dL in women or \< 13g/dL in men
  • Withdrawal of consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Obesity Centre

Yaoundé, Cameroon

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes MellitusInsulin Resistance

Interventions

LiraglutideVildagliptin

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinism

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1Glucagon-Like PeptidesProglucagonGastrointestinal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNitrilesOrganic ChemicalsPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Eugène Sobngwi

    Yaounde Central Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Endocrinology and Diabetes

Study Record Dates

First Submitted

July 12, 2016

First Posted

July 14, 2016

Study Start

January 1, 2016

Primary Completion

September 1, 2016

Study Completion

December 1, 2016

Last Updated

December 26, 2017

Record last verified: 2017-12

Locations

CA(1)