A study to determine the efficacy of a device for measuring blood glucose levels in type 2 diabetes patients on drug treatment with voglibose

A SINGLE ARM,OPEN-LABEL STUDY TO DETERMINE DAILY GLYCEMIC EXCURSIONS BY CONTINUOUS GLUCOSE MONITORING IN TYPE-2 DIABETIC PATIENTS RECEIVING VOGLIBOSE AS ADD-ON THERAPY IN INDIA

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2018/04/013074

Enrollment

110

Registered

2018-04-05

Start date

Unknown

Completion date

Unknown

Last updated

2024-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: voglibose, metformin, sulfonyl urea: Determine daily glycemic excursion by continuous glucose monitoring in Type 2 Diabetic patients biguanide and Sulfonlyurea versus Metformin along w

Eligibility

Inclusion criteria

Inclusion criteria: Type 2 Diabetes mellitus BMI > and equal to 23 kg/m2 Stable dose of metformin and / or Sulfonlyurea Complaint with CGMS device

Exclusion criteria

Exclusion criteria: Type 1 and GDM Known sensitivity to Voglibose Other major complications Pregnant and lactating woman

Design outcomes

Primary

Measure	Time frame
Change from baseline in average number of glycemic excursions per day at day 14 and 28 Change from baseline in percent time spent in glucose fluctuations at day 14 and 28 Timepoint: Change from baseline in average number of glycemic excursions per day at day 14 and 28 Change from baseline in percent time spent in glucose fluctuations at day 14 and 28	—

Secondary

Measure	Time frame
Change from baseline in mean post-prandial glucose AUC (Within 3 hours after each meal) at day 14 and 28 Nature and frequency of adverse events and treatment withdrawals due to AE’sTimepoint: 6 months	—

Countries

India

Contacts

Public ContactDR V MOHAN

MADRAS DIABETES RESEARCH FOUNDATION

drnohans@diabetes.ind.in914443968888

Outcome results