Clinical trial NCT02133118: Weight Trajectory in New Users of Sulfonylureas as Add on Therapy Next to Metformin.
Official title: A Prospective Observational Cohort Study; The Weight Trajectory in New Users of Sulfonylureas as Add on Therapy Next to Metformin.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 diabetes
New-user design
Weight trajectory
Add-on therapy
Sulphonylureas.
Lead sponsor: Medical Research Foundation, The Netherlands
Sponsor class: OTHER
First posted: 2014-05-07
Enrollment: 16293
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

Eligibility 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

Primary outcomes:
measure: The course of weight (Kg) after starting individual SU's, pioglitazone or insulin as add-on therapy.
timeFrame: Up to 5 years
Secondary outcomes:
measure: The course of the glycaemic control (HbA1c %) , up to five years after starting individual SU's, pioglitazone or insulin as add-on therapy.
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Zwolle
country: Netherlands
facility: Isala
state: Overijssel
Study officials:
affiliation: Isala, Diabetes Centre
name: G. W.D. Landman, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Isala, Diabetes Centre
name: R. Wever, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Isala, Diabetes Centre
name: P. R. van Dijk, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Diabetes Centre, Isala, Zwolle
name: Nanne Kleefstra, MD PhD
role: STUDY_DIRECTOR
References: