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

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: individual SUs, insulin, pioglitazone

• Registration Number: NCT02133118
• Lead Sponsor: Medical Research Foundation, The Netherlands

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 1998-01
• Study First Submitted: 2014-05-06
• Study First Submitted QC: 2014-05-06
• Study First Posted: 2014-05-07
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-14
• Last Update Posted: 2015-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16293

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients on metformin mono-therapy who receive add-on	individual SUs, insulin, pioglitazone	-

Primary Outcome Measures

Name	Time	Method
The course of weight (Kg) after starting individual SU's, pioglitazone or insulin as add-on therapy.	Up to 5 years	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.

Secondary Outcome Measures

Name	Time	Method
The course of the glycaemic control (HbA1c %) , up to five years after starting individual SU's, pioglitazone or insulin as add-on therapy.	Up to 5 years	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.

Trial Locations

Locations (1)

Isala; 🇳🇱 Zwolle, Overijssel, Netherlands