Phase 4
N=611
Impact of Dietary Intervention on Weight Change in Subjects With Type 2 Diabetes
Diabetes · Diabetes Mellitus, Type 2
Bottom Line
View on ClinicalTrials.gov: NCT01232491 ↗Enrolled (actual)
611
Serious AEs
5.9%
Results posted
Dec 2012
Primary outcome: Primary: Change From Baseline in Body Weight — -1.05; -0.56 kg — p=0.132
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Insulin detemir (Drug); Dietary regimen (Dietary_supplement)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novo Nordisk A/S
- Primary completion
- Nov 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Body Weight |
-1.05; -0.56 | 0.132 |
| SECONDARY Change From Baseline in Body Mass Index (BMI) |
-0.37; -0.20 | 0.137 |
| SECONDARY Change From Baseline in Glycosylated Haemoglobin (HbA1c) |
-0.93; -0.80 | 0.053 |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) |
-3.00; -2.93 | 0.674 |
| SECONDARY Rate of Treatment Emergent Adverse Events (TEAEs) |
387.9; 437.1; 16.3; 16.6; 16.3; 11.3 | — |
| SECONDARY Rate of All Treatment Emergent Hypoglycaemic Episodes |
25.47; 23.30; 0.01; 0.01 | — |
| SECONDARY Rate of Nocturnal Treatment Emergent Hypoglycaemic Episodes |
5.59; 5.51; 0.01; 0.01 | — |
Summary
This trial is conducted in Europe, and North and South America. The aim of this trial is to investigate if a dietary intervention has an effect on weight when initiating insulin treatment in subjects with type 2 diabetes currently treated with oral antidiabetic drugs (OADs).
Eligibility Criteria
Inclusion Criteria
- Type 2 diabetes (diagnosed clinically) for at least 6 months prior trial start
- Insulin naive subjects
- HbA1c: 7.0-9.0 % (both inclusive)
- Body Mass Index (BMI): 25.0-45.0 kg/m^2 (both inclusive)
Exclusion Criteria
- Use of Thiazolidinedione (TZDs) or Glucagon-like peptide-1 analogue (GLP- 1) receptor agonists within the last 3 months prior to trial enrollment
- Cardiovascular disease within the last 6 months
- Recurrent severe hypoglycaemia or hypoglycaemic unawareness or hospitalisation for diabetic ketoacidosis during the previous 6 months
- Uncontrolled treated/untreated severe hypertension, impaired liver function, impaired renal function, known proliferative retinopathy or maculopathy requiring treatment
- Cancer and medical history of cancer in the past 5 years (except basal cell skin cancer or squamous cell skin cancer)
- Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements
Data sourced from ClinicalTrials.gov (NCT01232491). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.