Prospective Diabetes Registry of Patients With Type 2 Diabetes Mellitus on SGLT 2 Inhibitor Therapy in Singapore

NCT02578563 | Completed DMC

• 1 other identifier: D1843R00258
• Study Type: observational
• Target: 201
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate clinical effectiveness and safety of Singaporean Type 2 Diabetes mellitus patients administered SGLT 2 inhibitor monotherapy or in combination with other commonly used hypoglycaemic drugs in real life clinical settings. To evaluate real life clinical effectiveness and safety of Sodium-Glucose Co-Transporter inhibitor- 2 in Singaporean Type 2 diabetes mellitus patients treated on an outpatient basis in clinical practice setting. The study would also assess treatment patterns with SGLT2 inhibitor patient relevant outcomes in whole population as well as pre identified patient subgroups. Primary analysis to be done at 1 year and extended analysis at 2 years.

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Change from baseline in the HbA1c level after 1 year

  to assess whether the therapy initiated with SGLT2 inhibitors at baseline is able to reduce the HbA1c after 1 year.

  baseline to 1 year

Secondary Outcomes (10)

• Change from baseline in FPG level at 6months

  Blood samples are collected pre-dose, 6 months post-dose

• Change from baseline in FPG level at 12months

  Blood samples are collected pre-dose, 12 months post-dose

• Change from baseline in weight at 6months

  weight is measured pre-dose, 6 months post-dose

• Change from baseline in weight at 12 months

  weight is measured pre-dose, 12 months post-dose

• Change from baseline in BP at 6 months

  BP is measured pre-dose, 6 months post-dose

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Simple random sample.

You may qualify if:

• Patients should meet all of the following criteria at Day 0:
• Outpatient equal to or more than 18 years of age
• Diagnosed as T2DM and treated with antidiabetic medicines at least 3 months and suitable for SGLT2 inhibitor as current treatment judged by PI with HbA1c \> 7.0 %
• Will provide completed and signed written informed consents Each participating investigator, will be asked to recruit a fixed number of patients ranging from 10 to 40 depending on site specificities.

You may not qualify if:

• Patients, with the following criteria will be excluded at Day 0:
• Hypersensitivity to any SGLT2 inhibitor or any of the components in the formulation
• Patients with Type 1 diabetes
• Female patients with gestational diabetes during pregnancy
• Female patients who are pregnant, intending to become pregnant or breastfeeding
• Severe medical condition(s) that in the view of the investigator prohibits participation in the study e.g. cancer, end stage liver disease, end stage renal failure (non-diabetes related)
• Use of other investigational drugs at the time of enrolment
• Renal Function: \<30ml/min/1.73m2

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Singapore, Singapore

Location

Related Publications (1)

• REFERENCES 1. Wang JS, et al. Diabetes Metab Res Rev. 2011;27:79-84 2. Bonora E, et al. Diabetes Care. 2001;24:2023-2029 3. Peter R, et al. Diabet Med. 2006;23:990-995 4. Venn BS, et al. Diabet Med. 2010;27:1205-1208 5. Henry CJ, et al. Br J Nutr. 2008;99:840-845 6. Bailey CJ, et al. Lancet. 2010;375:2223-33

  RESULT

Related Links

• CSR Synopsis

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2015
• First Posted: October 19, 2015
• Study Start: February 12, 2016
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: January 2, 2020

Record last verified: 2019-12

Locations

SG (1)