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

NCT02133118 | Completed

• 1 other identifier: ZODIAC
• Study Type: observational
• Target: 16,293
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 diabetes; New-user design; Weight trajectory; Add-on therapy; Sulphonylureas.

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (1)

Patients on metformin mono-therapy who receive add-on

Drug: individual SUs, insulin, pioglitazone

Interventions

individual SUs, insulin, pioglitazone DRUG

Patients on metformin mono-therapy who receive add-on

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

Sponsors & Collaborators

• Medical Research Foundation, The Netherlands: lead

Study Sites (1)

Isala

Zwolle, Overijssel, 8000 AB, Netherlands

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Body-Weight Trajectory

Interventions

Insulin; Pioglitazone

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• Nanne Kleefstra, MD PhD

  Diabetes Centre, Isala, Zwolle

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PHD

Study Record Dates

• First Submitted: May 6, 2014
• First Posted: May 7, 2014
• Study Start: January 1, 1998
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: March 17, 2015

Record last verified: 2015-03

Locations

NL (1)