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Comparison of Insulin Detemir Versus Insulin NPH on Weight Change in Overweight and Obese With Type 2 Diabetes

Comparison of the Effect of Insulin Detemir Versus Insulin NPH Both With Insulin Aspart on Weight Change in Overweight and Obese Subjects With Type 2 Diabetes

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00504673
Acronym
PREDICTIVE™
Enrollment
277
Registered
2007-07-20
Start date
2005-04-30
Completion date
2006-12-31
Last updated
2023-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Diabetes Mellitus, Type 2

Brief summary

This trial is conducted in Europe. The purpose of the trial is to investigate the effect of insulin detemir on weight change in overweight and obese patients with type 2 diabetes.

Interventions

DRUGinsulin detemir
DRUGinsulin NPH
DRUGinsulin aspart

Sponsors

Novo Nordisk A/S
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* HbA1c: 7.5-11.0% * BMI: 25-40 kg/m2

Exclusion criteria

* Treatment with any OAD (Oral Antidiabetic Drugs) except metformin

Design outcomes

Primary

MeasureTime frame
Body weight lossafter 26 weeks of treatment

Secondary

MeasureTime frame
HbA1c
Incidence of hypoglycaemia

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026