Comparison of a Basal Plus One Insulin Regimen With a Biphasic Insulin Regimen in Type 2 Diabetes Patients

Diabetes Mellitus, Type 2 Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00965549
• Other study ID #: LANTU_L_04211
• Secondary ID: 2008-007026-19(E
• Status: Completed
• Phase: Phase 4
• First received: August 24, 2009
• Last updated: January 7, 2013
• Start date: July 2009
• Est. completion date: December 2012

Study information

• Verified date: January 2013
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

The primary objective is to demonstrate the non-inferiority at six months of a basal plus one insulin regimen (Lantus plus one injection of Apidra) compared with a biphasic insulin regimen (NovoMix 30) at controlling glycosylated haemoglobin (HbA1c) in type 2 diabetes.

The secondary objective are:

• To compare the proportion of patients in each treatment group reaching HbA1c target (< 7%) at the end of the treatment period

• To compare the rates of hypoglycaemia (total, severe, nocturnal)

• To compare the change in body weight from visit 10 to visit 24

• To compare the change in diabetes specific quality of life and other patient reported outcomes from visit 10 to visit 24

• Diabetes Treatment Satisfaction Questionnaire - status and change (DTSQs+c)

• Audit of Diabetes-Dependent Quality of Life (ADDQoL) questionnaire

• Insulin Treatment Satisfaction Questionnaire (ITSQ)

• EuroQoL 5 Dimensions (EQ5D) questionnaire

• To record the change in the daily dose of insulin from visit 2 to visit 10 and visit 10 to visit 24

Recruitment information / eligibility

• Status: Completed
• Enrollment: 463
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion criteria:

• Type 2 diabetes mellitus

• 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 10.0% > or = HbA1c > or = 7.5%

• BMI < or = 40 kg/m²

• If patients are taking oral antidiabetics (OADs), the dose must be stable for at least 1 month

• Ability and willingness to perform blood glucose monitoring using a blood glucose meter and ability and willingness to use a patient diary

• Provision of written informed obtained prior to enrollment in the study

Exclusion criteria:

• Type 1 diabetes mellitus

• Current or previous treatment with an insulin other than basal insulin (biphasic insulin, short acting insulin, rapid-acting insulin analogue)

• Treatment with GLP-1 receptor agonists or with DPPIV inhibitors in the 3 months before screening

• 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 optic fundus exam performed in the 2 years prior to screening)

• Unable or unwilling to enter either of the treatment arms

• 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)

• History of hypersensitivity to the study drugs or to drugs with a similar chemical structure

• Treatment with systemic corticosteroids in the 3 months prior to study entry

• Treatment with any investigational product in the 2 months prior to study entry

• Current treatment with any non-selective beta-blockers

• Likelihood of requiring treatment during the study period with drugs not permitted by this clinical protocol

• Clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major disease making implementation of the protocol or interpretation of the study results difficult

• Impaired hepatic function as shown by ALT and/or AST greater than three times the upper limit of normal at screening

• Impaired renal function as shown by serum creatinine >135 µmol/l in men and > 110 µmol/l in women at screening

• History of drug or alcohol abuse

• Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study

• Patient unlikely to comply with protocol, e.g. uncooperative attitude, inability to return for follow-up visits, or unlikely to complete the study

• Patient is the investigator or any sub investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Drug:
• INSULIN GLARGINE (HOE901)
LANTUS®: Solution for injection. 100U/mL in a prefilled pen (SoloStar®)
• Insulin aspart
NovoMix® 30: Suspension for injection. 100U/mL in a prefilled pen (FlexPen®)
• Insulin Glulisine
APIDRA®: Solution for injection. 100U/mL in a prefilled pen (SoloStar®)

Locations

Country	Name	City	State
Australia	Investigational Site Number 204	Campbelltown
Australia	Investigational Site Number 205	Campbelltown
Australia	Investigational Site Number 201	Caulfield
Australia	Investigational Site Number 210	Daw Park
Australia	Investigational Site Number 214	Douglas
Australia	Investigational Site Number 203	Heidelberg
Australia	Investigational Site Number 206	Herston
Australia	Investigational Site Number 211	Maroubra
Australia	Investigational Site Number 207	Meadowbrook
Australia	Investigational Site Number 212	Melbourne
Australia	Investigational Site Number 209	Milton
Australia	Investigational Site Number 213	Nowra
Australia	Investigational Site Number 202	Parkville
Australia	Investigational Site Number 208	Southport
United Kingdom	Investigational Site Number 826-109	Aberdeen
United Kingdom	Investigational Site Number 826-118	Ashton-under-Lyne
United Kingdom	Investigational Site Number 826-157	Ayr
United Kingdom	Investigational Site Number 826-149	Barnsley
United Kingdom	Investigational Site Number 826-135	Bath
United Kingdom	Investigational Site Number 826-124	Birmingham
United Kingdom	Investigational Site Number 826-150	Birmingham
United Kingdom	Investigational Site Number 826-106	Bournemouth
United Kingdom	Investigational Site Number 826-136	Bradford
United Kingdom	Investigational Site Number 826-130	Bristol
United Kingdom	Investigational Site Number 826-114	Bury St Edmunds
United Kingdom	Investigational Site Number 826-132	Carmarthen
United Kingdom	Investigational Site Number 826-141	Cheadle
United Kingdom	Investigational Site Number 826-147	Chester
United Kingdom	Investigational Site Number 826-112	Chesterfield
United Kingdom	Investigational Site Number 826-152	Chichester
United Kingdom	Investigational Site Number 826-159	Cleveleys
United Kingdom	Investigational Site Number 826-113	Colchester
United Kingdom	Investigational Site Number 826-119	Cornwall
United Kingdom	Investigational Site Number 826-162	Crawley
United Kingdom	Investigational Site Number 826-145	Dafen
United Kingdom	Investigational Site Number 826-165	Dumfries
United Kingdom	Investigational Site Number 826-167	Durham
United Kingdom	Investigational Site Number 826-173	East Kilbride
United Kingdom	Investigational Site Number 826-105	Edinburgh
United Kingdom	Investigational Site Number 826-115	Exeter
United Kingdom	Investigational Site Number 826-160	Fleetwood
United Kingdom	Investigational Site Number 826-107	Gateshead
United Kingdom	Investigational Site Number 826-127	Glasgow
United Kingdom	Investigational Site Number 826-174	Haddington
United Kingdom	Investigational Site Number 826-164	Hereford
United Kingdom	Investigational Site Number 826-126	High Wycombe
United Kingdom	Investigational Site Number 826-102	Hull
United Kingdom	Investigational Site Number 826-120	Ipswich
United Kingdom	Investigational Site Number 826-163	Kirkcaldy
United Kingdom	Investigational Site Number 826-161	Lancaster
United Kingdom	Investigational Site Number 826-101	Liverpool
United Kingdom	Investigational Site Number 826-108	Liverpool
United Kingdom	Investigational Site Number 826-122	Livingston
United Kingdom	Investigational Site Number 826-110	Llantrisant
United Kingdom	Investigational Site Number 826-123	London
United Kingdom	Investigational Site Number 826-142	London
United Kingdom	Investigational Site Number 826-166	London
United Kingdom	Investigational Site Number 826-137	Manchester
United Kingdom	Investigational Site Number 826-156	Mortimer
United Kingdom	Investigational Site Number 826-140	Newcastle upon Tyne
United Kingdom	Investigational Site Number 826-138	Newport
United Kingdom	Investigational Site Number 826-133	Nottingham
United Kingdom	Investigational Site Number 826-121	Nuneaton
United Kingdom	Investigational Site Number 826-129	Plymouth
United Kingdom	Investigational Site Number 826-116	Salford
United Kingdom	Investigational Site Number 826-143	Scunthorpe
United Kingdom	Investigational Site Number 826-104	Sheffield
United Kingdom	Investigational Site Number 826-103	St Helens
United Kingdom	Investigational Site Number 826-139	St Leonards on Sea
United Kingdom	Investigational Site Number 826-111	Stevenage
United Kingdom	Investigational Site Number 826-131	Stirling
United Kingdom	Investigational Site Number 826-146	Sunderland
United Kingdom	Investigational Site Number 826-128	Westbury
United Kingdom	Investigational Site Number 826-117	York

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

Australia,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycosylated Haemoglobin (HbA1c)		At week 7 and week 32	No
Secondary	Weight		At week 8 and week 32	No
Secondary	Diabetes specific quality of life measured using ADDQoL (Audit of Diabetes-Dependent Quality of Life questionnaire) and other patient reported outcomes measured using EQ5D (EuroQoL 5 Dimensions questionnaire)		Week 8 and week 32	No
Secondary	Hypoglycaemia (total, severe and nocturnal)		At week 0 and week 32	No