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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02133118
Recruitment Status : Completed
First Posted : May 7, 2014
Last Update Posted : March 17, 2015
Sponsor:
Information provided by (Responsible Party):
Gijs Landman, Medical Research Foundation, The Netherlands

Study Description
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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.


Condition or disease Intervention/treatment
Type 2 Diabetes Mellitus 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 Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 16293 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: A Prospective Observational Cohort Study; The Weight Trajectory in New Users of Sulfonylureas as Add on Therapy Next to Metformin.
Study Start Date : January 1998
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

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


Outcome Measures
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Primary Outcome Measures :
  1. The course of weight (Kg) after starting individual SU's, pioglitazone or insulin as add-on therapy. [ Time Frame: 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 :
  1. The course of the glycaemic control (HbA1c %) , up to five years after starting individual SU's, pioglitazone or insulin as add-on therapy. [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02133118


Locations
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Netherlands
Isala
Zwolle, Overijssel, Netherlands, 8000 AB
Sponsors and Collaborators
Medical Research Foundation, The Netherlands
Investigators
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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
More Information
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Additional Information:

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Responsible Party: Gijs Landman, MD, PHD, Medical Research Foundation, The Netherlands
ClinicalTrials.gov Identifier: NCT02133118    
Other Study ID Numbers: ZODIAC
First Posted: May 7, 2014    Key Record Dates
Last Update Posted: March 17, 2015
Last Verified: March 2015
Keywords provided by Gijs Landman, Medical Research Foundation, The Netherlands:
Type 2 diabetes
New-user design
Weight trajectory
Add-on therapy
Sulphonylureas.
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Body-Weight Trajectory
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Body Weight Changes
Body Weight
Pioglitazone
Hypoglycemic Agents
Physiological Effects of Drugs