A randomised, controlled, parallel, open-labelled, multinational, trial comparing the efficacy and safety of step-wise addition of insulin aspart (NovoRapid®) according to the largest meals (Basic Basal Plus regimen) or the largest prandial increments (Advanced Basal Plus regimen) in combination with once daily insulin detemir (Levemir®) and OAD treatment, in subjects with type 2 diabetes

Phase 1

• Conditions: type 2 diabetes; MedDRA version: 9.1Level: LLTClassification code 10045242Term: Type II diabetes mellitus

• Registration Number: EUCTR2007-000123-18-FR
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-07-25
• Study Completion: 2009-03-18
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 0

Inclusion Criteria

1.Signed informed consent obtained before any trial-related activities (Trial related activities are any procedure that would not have been performed during the normal management of the subject)
2.Type 2 diabetes mellitus = 6 months (at visit 2)
3.Age = 18 years (at visit 1)
4.HbA1c = 7.5% and < 10.0% (at Visit 1)
5.BMI < 40.0 kg/m2
6.Basal insulin treatment (NPH once or twice daily, insulin glargine once daily or IDet once daily) for at least 3 months (at Visit 2)
7.Treatment with 1-3 OADs
a.Metformin = 1500 mg daily or highest tolerable dose
b.± SU = 50% of maximum dose (in accordance with local labelling)
c.± Pioglitazone or Rosiglitazone in accordance with local labelling
8.Able and willing to perform SMPG testing as per protocol
9.Able and willing to eat 3 main meals each day during the trial
10.Able and willing to adhere to the therapeutic regimens

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Known or suspected allergy to trial product(s) or related products
2.Previous participation in any trial for the last 3 months
3.Previous participation in this trial defined as past inclusion at visit 2
4.Women of childbearing potential who are pregnant, breast-feeding or intend to become pregnant within the next 50 weeks or are not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practice).
UK: Adequate contraceptive measures are defined as sterilisation, intra-uterine device, oral contraceptives or consistent use of barrier methods
5.Use of more than 1 U/kg of basal insulin daily (at Visit 1)
6.Treatment with a -glucosidase inhibitors (at Visit 1)
7.Treatment with GLP-1 mimetics or DPP-IV inhibitors (at Visit 1)
8.Active proliferative retinopathy or maculopathy requiring treatment within 6 mnths prior to screening
9.Cardiac disease defined as NYHA class III or IV, unstable angina and/or myocardial infarction within 6 months prior to screening
10.Uncontrolled hypertension (treated or untreated) as judged by the Investigator
11.Any disease or condition (such as renal, hepatic or cardiac) that according to the judgement of the Investigator makes the subject unsuitable for participation in the trial
12.Recurrent (> 2 episodes) hypoglycaemia with PG < 3.1 mmol/L (55.8 mg/dL) within the last month or hypoglycaemic unawareness as judged by the investigator
13.Use of concomitant medication which may alter glucose metabolism including but not limited to: systemic (or inhaled) glucocorticoids or non-selective beta-blockers
14.Substance abuse including abuse of anabolic steroids
15.Mental incapacity or language barrier precluding adequate understanding and/or cooperation
16.Any condition that the investigator and/or Sponsor consider a potential obstacle to trial participation and/or data analysis
17.Treatment with other insulin than those described in inclusion criteria no. 6

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified