Weight Trajectory in New Users of Sulfonylureas as Add on Therapy Next to Metformin.

Type 2 Diabetes Mellitus Clinical Trial

— ZODIAC-39  

Official title:

A Prospective Observational Cohort Study; The Weight Trajectory in New Users of Sulfonylureas as Add on Therapy Next to Metformin.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02133118
• Other study ID #: ZODIAC
• Status: Completed
• Phase: N/A
• First received: May 6, 2014
• Last updated: March 14, 2015
• Start date: January 1998
• Est. completion date: December 2014

Study information

• Verified date: March 2015
• Source: Medical Research Foundation, The Netherlands
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Next to HbA1c, body weight is regarded as an important surrogate end-point in trials investigating glucose-lowering agents. An increase in weight could contribute to worsening insulin resistance. Differences in weight after starting glucose lowering agents have been described in many randomized controlled trials (RCTs).

With this prospective observational study, weight trajectories after receiving add-on therapy next to metformin are evaluated in primary care patients with good glycaemic control.

Description:

This prospective cohort study is part of the ZODIAC (Zwolle Outpatient Diabetes project Integrating Available Care) study, which started in 1998 as a prospective observational study and includes patients with known T2DM who are treated in primary care.

The investigators aim to investigate the course of the bodyweight and glycaemic control, the years after starting specific SU's, pioglitazone or insulin as add-on therapy, in metformin treated primary care patients with T2DM.

As part of the process called benchmarking, a dataset of quality measures is collected annually for all patients participating in the ZODIAC study during the patient's visit to the practice nurse and/or general practitioner and sent to the investigators' diabetes centre for benchmarking and research purposes once a year.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16293
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• T2DM

• Treated in primary care in period 1998 to 2012

• used metformin monotherapy

• subsequently received add-on therapy with a SU or pioglitazone during their entire follow-up period

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• individual SUs, insulin, pioglitazone

Locations

Country	Name	City	State
Netherlands	Isala	Zwolle	Overijssel

Sponsors (1)

Lead Sponsor	Collaborator
Medical Research Foundation, The Netherlands

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The course of weight (Kg) after starting individual SU's, pioglitazone or insulin as add-on therapy.	The course of the bodyweight up to five years after starting individual SU's (gliclazide/glibenclamide/tolbutamide/glimepiride), pioglitazone or insulin as add-on therapy, in metformin treated primary care patients with T2DM.	Up to 5 years	No
Secondary	The course of the glycaemic control (HbA1c %) , up to five years after starting individual SU's, pioglitazone or insulin as add-on therapy.	The course of the glycaemic control, up to five years after starting individual SU's (gliclazide, glibenclamide, tolbutamide, glimepiride), pioglitazone or insulin as add-on therapy, in metformin treated primary care patients with T2DM.	Up to 5 years	No