Clinical trial NCT00849342: Observational Study on Levemir® in Obese Diabetic Patients
Official title: A Prospective, Multicentre, Non-controlled, Observational, 52-weeks Study: the Evaluation of the Body Weight Progress During the Treatment With Insulin Detemir in Type 1 or 2 Diabetes Patients, Previously Treated With Other Basal Insulins
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2009-02-23
Enrollment: 580
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from both general and speciality practice settings who have been deemed appropriate to receive Levemir® because of weight increase on other insulin therapies, and as part of routine out-patient care by the prescribing physician.

Brief summary: This study is conducted in Europe. The aim of this observational study is to investigate the effect of switch from other basal insulin treatments to Levemir® on body weight in obese diabetic patients. A local extension will be conducted in Slovenia in order to reach the planned 400 patients for the sub-analysis of Slovenian patients.

Included in the study is a retrospective part to evaluate the weight progress since initiation of insulin treatment of another basal insulin and/or oral antidiabetic drugs (OAD) and/or bolus insulin therapy. Retrospective data will be collected at baseline and at approximately 6 and 12 months before starting insulin detemir therapy.


Eligibility criteria: Inclusion Criteria:

* Diabetes mellitus (Type 1 or type 2)
* BMI greater than 27 kg/m\^2, or more than 3 kg weight increase since start of insulin therapy

Exclusion Criteria:

* Subjects currently being treated with insulin detemir
* Subjects who were previously enrolled in this study;
* Subjects with a hypersensitivity to insulin detemir or to any of the excipients.
* Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 12 months Female patients will be reminded to use adequate contraceptive during the study, where is relevant.

Primary outcomes:
measure: Change in body weight and BMI
timeFrame: during 12 months of treatment
Secondary outcomes:
measure: Change in body weight at different BMI subgroups
timeFrame: at insulin start, 12 and 6 months before treatment and after 3, 6, 9 and 12 months of treatment
measure: Change in waist perimeter
timeFrame: from insulin start and after 6 and 12 months of treatment
measure: Change in FPG (Fasting Plasma Glucose)
timeFrame: from 12 and 6 months before treatment after 6 and 12 months of treatment
measure: Change in HbA1C
timeFrame: from insulin start and 12 and 6 months before treatment and after 6 and 12 months of treatment
measure: Change in number of hypoglycaemic events during 4 weeks proceeding routine visits
timeFrame: after 6 and 12 months of treatment
measure: Number of adverse drug reactions (ADR)
timeFrame: after 6 and 12 months of treatment
measure: Change in blood pressure
timeFrame: from insulin start and 6 and 12 months after treatment
Other outcomes:
Locations:
city: Alphen a/d Rijn
country: Netherlands
city: Ljubljana
country: Slovenia
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References: