NCT04654676

Brief Summary

The investigators conducted a prospective study in patients with T2DM on twice daily MHI with or without metformin therapy. Blinded continuous glucose monitoring was performed at baseline and following 6 weeks of Vildagliptin therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

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

Timeline
Completed

Started Sep 2018

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

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2019

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 12, 2020

Completed
22 days until next milestone

First Posted

Study publicly available on registry

December 4, 2020

Completed
Last Updated

December 19, 2020

Status Verified

December 1, 2020

Enrollment Period

12 months

First QC Date

November 12, 2020

Last Update Submit

December 16, 2020

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Changes in mean amplitude of glycemic excursions in mmol/L, Standard deviation of the mean glucose levels in mmol/L, M value in mmol/L, Mean absolute glucose in mmol/L, Continuous overlapping net glycemic action in mmol/L, Lability index in mmol/L

    Glycemic variability

    12 months

Secondary Outcomes (3)

  • Estimated HbA1c in %, % time in range (TIR) in %, % time above range (TAR) in %, % time below range (TBR) in %, % time below 3.0 mmol/L in %

    12 months

  • Low blood glucose index (LBGI) in mmol/L, High blood glucose index (HBGI) in mmol/L

    12 months

  • Area under curve above 10.0mmol/day, area under curve below 3.9mmol/day

    12 months

Interventions

VildagliptinDRUG

Vildagliptin added on to stable doses of pre-mixed insulin with or without metformin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • HbA1c 7-10%
  • Treated with stable dose of twice daily pre-mixed human insulin for at least 3 months, with or without metformin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sarawak General Hospital

Kuching, Malaysia

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Vildagliptin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

NitrilesOrganic ChemicalsPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Florence Tan

    Sarawak General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2020

First Posted

December 4, 2020

Study Start

September 15, 2018

Primary Completion

August 31, 2019

Study Completion

August 31, 2019

Last Updated

December 19, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

MY(1)