Weight Trajectory in New Users of Sulfonylureas as Add on Therapy Next to Metformin. (ZODIAC-39)

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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: individual SUs, insulin, pioglitazone

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 Type: Observational
• Enrollment (Actual): 16293

Contacts and Locations

Study Locations

• Netherlands
  • Overijssel
    • Zwolle, Overijssel, Netherlands, 8000 AB
      • Isala

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with T2DM who received monotherapy with metformin and needed treatment intensification by receiving add-on therapy next to metformin

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients on metformin mono-therapy who receive add-on	Drug: individual SUs, insulin, pioglitazone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Medical Research Foundation, The Netherlands
• Investigators: Principal Investigator: G. W.D. Landman, MD PhD, Isala, Diabetes Centre; Principal Investigator: R. Wever, MD, Isala, Diabetes Centre; Principal Investigator: P. R. van Dijk, MD, Isala, Diabetes Centre; Study Director: Nanne Kleefstra, MD PhD, Diabetes Centre, Isala, Zwolle

Study record dates

Study Major Dates

• Study Start: January 1, 1998
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: May 6, 2014
• First Submitted That Met QC Criteria: May 6, 2014
• First Posted (Estimate): May 7, 2014

Study Record Updates

• Last Update Posted (Estimate): March 17, 2015
• Last Update Submitted That Met QC Criteria: March 14, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: Type 2 diabetes; Add-on therapy; New-user design; Weight trajectory; Sulphonylureas.
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Body Weight; Body Weight Changes; Diabetes Mellitus, Type 2; Body-Weight Trajectory; Hypoglycemic Agents; Physiological Effects of Drugs; Pioglitazone
• Other Study ID Numbers: ZODIAC