COMPARISON OF A BASAL PLUS ONE INSULIN REGIMEN (INSULIN GLARGINE/INSULIN GLULISINE) WITH A BIPHASIC INSULIN REGIMEN (INSULIN ASPART/INSULIN ASPART PROTAMINE 30/70) IN TYPE 2 DIABETES PATIENTS FOLLOWING BASAL INSULIN OPTIMISATION - LanScape

Phase 1

• Conditions: Type II diabetes mellitus; MedDRA version: 9.1 Level: LLT Classification code 10012601 Term: Diabetes mellitus

• Registration Number: EUCTR2008-007026-19-GB
• Lead Sponsor: Aventis Pharma Ltd trading as sanofi-aventis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-04-16
• Study Completion: 2012-12-20
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 780

Inclusion Criteria

Main inclusion criteria:
1.Men or women, aged 18 to 75
2.Type 2 diabetes mellitus
3.Patients being treated with Lantus® once daily, Levemir once or twice daily or NPH insulin once or twice daily as a single insulin for at least three months
4. 11.0% = HbA1c = 7.5%
5.BMI < 40
6.If patients are taking OADs, the dose must be stable for at least 1 month.
7.Ability and willingness to perform blood glucose monitoring using a blood glucose meter and ability and willingness to use a patient diary
8.Provision of written informed consent obtained prior to enrollment in the study

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

Main exclusion criteria:
1.Type 1 diabetes mellitus
2.Current or previous treatment with an insulin other than basal insulin (biphasic insulin, short acting insulin, rapid-acting insulin analogue) in the 3 month prior to screening
3.Treatment with GLP-1 receptor agonists or with DPP-IV inhibitors in the 3 months before screening
4.Active proliferative diabetic retinopathy, as defined by the application of photocoagulation or surgery, in the 6 months before screening or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgery during the study (confirmed by an appropriate fundus examination performed in the 2 years prior to screening, such as retinal photograph or fundoscopy)
5.Unable or unwilling to enter either of the treatment arms
6.Women who are pregnant or lactating (women of childbearing potential must have a negative pregnancy test at study entry and a medically approved contraceptive method)
7.History of hypersensitivity to the study drugs or to drugs with a similar chemical structure
8.Treatment with systemic corticosteroids in the 3 months prior to study entry
9.Treatment with any investigational product in the 2 months prior to study entry
10.Current treatment with any non-selective beta-blockers
11.Likelihood of requiring treatment during the study period with drugs not permitted by this clinical protocol
12.Clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major disease making implementation of the protocol or interpretation of the study results difficult
13.Impaired hepatic function as shown by ALT and/or AST greater than three times the upper limit of normal at screening
14.Impaired renal function as shown by serum creatinine>150 µmol/l in men or women at screening
15.History of drug or alcohol abuse
16.Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study
17.Patient unlikely to comply with protocol, e.g. uncooperative attitude, inability to return for follow-up visits, or unlikey to complete the study
18.Patient is the investigator or any sub investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol or a relative thereof.

Study & Design

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