Clinical Trials Logo
  1. Home
  2. Type 2 Diabetes
  3. NCT04132934
  4. Details
NCT04132934 Clinical Trial

Observational Study of Effectiveness and Tolerability of Gliclazide MR 60mg in Diabetic Patients Fasting During RAMADAN

Type 2 Diabetes Clinical Trial

— DIA-RAMADAN  

Official title:
Observational Study Program Assessing Effectiveness and Tolerability of Gliclazide MR 60mg in Patients With Type 2 Diabetes Fasting During RAMADAN

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04132934
Other study ID # DIM-05762-004
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 11, 2019
Est. completion date October 4, 2019

Study information
Verified date June 2020
Source Servier
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this observational study is to assess effectiveness and tolerability of gliclazide MR 60mg during RAMADAN in a real world setting in 9 countries from Asia Pacific and Middle East/North Africa

Recruitment information / eligibility
Status Completed
Enrollment 1200
Est. completion date October 4, 2019
Est. primary completion date October 4, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Informed consent obtained before any trial-related activities

- Male or female type 2 diabetic patients aged >18 years

- Patients with controlled or suboptimal controlled type 2 diabetes

- Patients with experience in SMBG controlling using glucometer

- Patients who are willing to fast during Ramadan

- Patients already treated with Gliclazide MR 60mg

Exclusion Criteria:

- Insulin therapy requirement

- Severe liver or renal failure

- HbA1c = 9%

- Contraindication to gliclazide according to SmPC

- Pregnancy or breast feeding

- Previous experience of severe or repeated hypoglycemia events without triggered factor within the previous year

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France Servier Affaires Medicales Suresnes

Sponsors (1)
Lead Sponsor Collaborator
Servier Affaires Médicales

Country where clinical trial is conducted

France, 

References & Publications (1)

Hassanein M, Al Sifri S, Shaikh S, Abbas Raza S, Akram J, Pranoto A, Rudijanto A, Shaltout I, Fariduddin M, Mohd Izani Wan Mohamed W, Al Awadi F, Alessa T; DIA-RAMADAN study investigators. A real-world study in patients with type 2 diabetes mellitus treat — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Proportion of patients with at least one Hypoglycemia event up to 5 months
See also
  Status Clinical Trial Phase
Completed NCT05219994 - Targeting the Carotid Bodies to Reduce Disease Risk Along the Diabetes Continuum N/A
Completed NCT04056208 - Pistachios Blood Sugar Control, Heart and Gut Health Phase 2
Completed NCT02284893 - Study to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin in Combination With Metformin Compared to Sitagliptin in Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone Phase 3
Completed NCT04274660 - Evaluation of Diabetes and WELLbeing Programme N/A
Active, not recruiting NCT05887817 - Effects of Finerenone on Vascular Stiffness and Cardiorenal Biomarkers in T2D and CKD (FIVE-STAR) Phase 4
Active, not recruiting NCT05566847 - Overcoming Therapeutic Inertia Among Adults Recently Diagnosed With Type 2 Diabetes N/A
Recruiting NCT06007404 - Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
Completed NCT04965506 - A Study of IBI362 in Chinese Patients With Type 2 Diabetes Phase 2
Recruiting NCT06115265 - Ketogenic Diet and Diabetes Demonstration Project N/A
Active, not recruiting NCT03982381 - SGLT2 Inhibitor or Metformin as Standard Treatment of Early Stage Type 2 Diabetes Phase 4
Completed NCT04971317 - The Influence of Simple, Low-Cost Chemistry Intervention Videos: A Randomized Trial of Children's Preferences for Sugar-Sweetened Beverages N/A
Completed NCT04496154 - Omega-3 to Reduce Diabetes Risk in Subjects With High Number of Particles That Carry "Bad Cholesterol" in the Blood N/A
Completed NCT04023539 - Effect of Cinnamomum Zeylanicum on Glycemic Levels of Adult Patients With Type 2 Diabetes N/A
Recruiting NCT05572814 - Transform: Teaching, Technology, and Teams N/A
Enrolling by invitation NCT05530356 - Renal Hemodynamics, Energetics and Insulin Resistance: A Follow-up Study
Completed NCT03960424 - Diabetes Management Program for Hispanic/Latino N/A
Completed NCT04097600 - A Research Study Comparing Active Drug in the Blood in Healthy Participants Following Dosing of the Current and a New Formulation (D) Semaglutide Tablets Phase 1
Completed NCT05378282 - Identification of Diabetic Nephropathy Biomarkers Through Transcriptomics
Active, not recruiting NCT06010004 - A Long-term Safety Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes Phase 3
Completed NCT03653091 - Safety & Effectiveness of Duodenal Mucosal Resurfacing (DMR) Using the Revita™ System in Treatment of Type 2 Diabetes N/A

External Links