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

NCT00965549 | Completed Phase 4

• 2 other identifiers: LANTU_L_042112008-007026-19(EudraCT)
• Study Type: interventional
• Target: 463
• Locations: 2 countries
• Sites: 74

Brief 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

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Glycosylated Haemoglobin (HbA1c)

  At week 7 and week 32

Secondary Outcomes (3)

• Weight

  At week 8 and week 32

• 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

• Hypoglycaemia (total, severe and nocturnal)

  At week 0 and week 32

Study Arms (2)

Lantus + Apidra basal plus one

EXPERIMENTAL

Before randomization (common with arm 2): A 1 to 2 weeks of screening period: patients will continue on their current insulin and oral antidiabetic drug (OAD) therapy. 8 weeks of run-in period: patients will switch their treatment for insulin glargine (one daily injection at bedtime) and all OADs (with the exception of metformin) will be discontinued. After randomization: 24 weeks of treatment period: Insulin (Lantus®) + metformin (if applicable) + a single injection of insulin glulisine (Apidra®), the latter administered at the patients largest meal of the day

Drug: INSULIN GLARGINE (HOE901); Drug: Insulin Glulisine

NovoMix 30 Biphasic

ACTIVE COMPARATOR

Before randomization (common with arm 1): A 1 to 2 weeks of screening period: patients will continue on their current insulin and oral antidiabetic drug (OAD) therapy. 8 weeks of run-in period: patients will switch their treatment for insulin glargine (one daily injection at bedtime) and all OADs (with the exception of metformin) will be discontinued. After randomization: 24 weeks of treatment period: Insulin aspart/ insulin protamine crystallised insulin aspart (NovoMix® 30) + metformin (if applicable)

Drug: Insulin aspart

Interventions

INSULIN GLARGINE (HOE901) DRUG

LANTUS®: Solution for injection. 100U/mL in a prefilled pen (SoloStar®)

Lantus + Apidra basal plus one

Insulin aspart DRUG

NovoMix® 30: Suspension for injection. 100U/mL in a prefilled pen (FlexPen®)

NovoMix 30 Biphasic

Insulin Glulisine DRUG

APIDRA®: Solution for injection. 100U/mL in a prefilled pen (SoloStar®)

Lantus + Apidra basal plus one

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sanofi: lead

Study Sites (74)

Investigational Site Number 204

Campbelltown, 2560, Australia

Location

Investigational Site Number 205

Campbelltown, 2560, Australia

Location

Investigational Site Number 201

Caulfield, 3162, Australia

Location

Investigational Site Number 210

Daw Park, 5041, Australia

Location

Investigational Site Number 214

Douglas, 4814, Australia

Location

Investigational Site Number 203

Heidelberg, 3081, Australia

Location

Investigational Site Number 206

Herston, 4006, Australia

Location

Investigational Site Number 211

Maroubra, 2035, Australia

Location

Investigational Site Number 207

Meadowbrook, 4131, Australia

Location

Investigational Site Number 212

Melbourne, 3065, Australia

Location

Investigational Site Number 209

Milton, 4064, Australia

Location

Investigational Site Number 213

Nowra, 2541, Australia

Location

Investigational Site Number 202

Parkville, 3050, Australia

Location

Investigational Site Number 208

Southport, 4215, Australia

Location

Investigational Site Number 826-109

Aberdeen, AB251LD, United Kingdom

Location

Investigational Site Number 826-118

Ashton-under-Lyne, OL69RW, United Kingdom

Location

Investigational Site Number 826-157

Ayr, KA66DX, United Kingdom

Location

Investigational Site Number 826-149

Barnsley, S752EP, United Kingdom

Location

Investigational Site Number 826-135

Bath, BA13NG, United Kingdom

Location

Investigational Site Number 826-124

Birmingham, B187QH, United Kingdom

Location

Investigational Site Number 826-150

Birmingham, B95SS, United Kingdom

Location

Investigational Site Number 826-106

Bournemouth, BH77DW, United Kingdom

Location

Investigational Site Number 826-136

Bradford, BD96RJ, United Kingdom

Location

Investigational Site Number 826-130

Bristol, BS105NB, United Kingdom

Location

Investigational Site Number 826-114

Bury St Edmunds, IP332QZ, United Kingdom

Location

Investigational Site Number 826-132

Carmarthen, SA312AF, United Kingdom

Location

Investigational Site Number 826-141

Cheadle, SK86LU, United Kingdom

Location

Investigational Site Number 826-147

Chester, CH21UL, United Kingdom

Location

Investigational Site Number 826-112

Chesterfield, S404TF, United Kingdom

Location

Investigational Site Number 826-152

Chichester, PO196SE, United Kingdom

Location

Investigational Site Number 826-159

Cleveleys, FY53LF, United Kingdom

Location

Investigational Site Number 826-113

Colchester, CO45JL, United Kingdom

Location

Investigational Site Number 826-119

Cornwall, TR13LJ, United Kingdom

Location

Investigational Site Number 826-162

Crawley, RH107DX, United Kingdom

Location

Investigational Site Number 826-145

Dafen, SA14 8QF, United Kingdom

Location

Investigational Site Number 826-165

Dumfries, DG14AP, United Kingdom

Location

Investigational Site Number 826-167

Durham, DH15TW, United Kingdom

Location

Investigational Site Number 826-173

East Kilbride, G758RG, United Kingdom

Location

Investigational Site Number 826-105

Edinburgh, EH164SA, United Kingdom

Location

Investigational Site Number 826-115

Exeter, EX25DW, United Kingdom

Location

Investigational Site Number 826-160

Fleetwood, FY76HD, United Kingdom

Location

Investigational Site Number 826-107

Gateshead, NE96SX, United Kingdom

Location

Investigational Site Number 826-127

Glasgow, G213UW, United Kingdom

Location

Investigational Site Number 826-174

Haddington, EH413PF, United Kingdom

Location

Investigational Site Number 826-164

Hereford, HR12RE, United Kingdom

Location

Investigational Site Number 826-126

High Wycombe, HP112TT, United Kingdom

Location

Investigational Site Number 826-102

Hull, HU32JZ, United Kingdom

Location

Investigational Site Number 826-120

Ipswich, IP45PD, United Kingdom

Location

Investigational Site Number 826-163

Kirkcaldy, KY25AH, United Kingdom

Location

Investigational Site Number 826-161

Lancaster, LA11RP, United Kingdom

Location

Investigational Site Number 826-101

Liverpool, L78XP, United Kingdom

Location

Investigational Site Number 826-108

Liverpool, L97AL, United Kingdom

Location

Investigational Site Number 826-122

Livingston, EH546PP, United Kingdom

Location

Investigational Site Number 826-110

Llantrisant, CF728XR, United Kingdom

Location

Investigational Site Number 826-142

London, N18 1QX, United Kingdom

Location

Investigational Site Number 826-123

London, N195NF, United Kingdom

Location

Investigational Site Number 826-166

London, W91SP, United Kingdom

Location

Investigational Site Number 826-137

Manchester, M85RB, United Kingdom

Location

Investigational Site Number 826-156

Mortimer, RG7 3SQ, United Kingdom

Location

Investigational Site Number 826-140

Newcastle upon Tyne, NE46BE, United Kingdom

Location

Investigational Site Number 826-138

Newport, PO305TG, United Kingdom

Location

Investigational Site Number 826-133

Nottingham, NG72UH, United Kingdom

Location

Investigational Site Number 826-121

Nuneaton, CV107DJ, United Kingdom

Location

Investigational Site Number 826-129

Plymouth, PL53JB, United Kingdom

Location

Investigational Site Number 826-139

Saint Leonards-on-Sea, TN377RD, United Kingdom

Location

Investigational Site Number 826-116

Salford, M68HD, United Kingdom

Location

Investigational Site Number 826-143

Scunthorpe, DN15 7BH, United Kingdom

Location

Investigational Site Number 826-104

Sheffield, S57AU, United Kingdom

Location

Investigational Site Number 826-103

St Helens, WA93DA, United Kingdom

Location

Investigational Site Number 826-111

Stevenage, SG14AB, United Kingdom

Location

Investigational Site Number 826-131

Stirling, FK82AU, United Kingdom

Location

Investigational Site Number 826-146

Sunderland, SR47TP, United Kingdom

Location

Investigational Site Number 826-128

Westbury, BA133JD, United Kingdom

Location

Investigational Site Number 826-117

York, YO318HE, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Glargine; Insulin Aspart; insulin glulisine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Insulin, Short-Acting

Study Officials

• Christine van Schalkwyk, MD

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2009
• First Posted: August 25, 2009
• Study Start: July 1, 2009
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: January 8, 2013

Record last verified: 2013-01

Locations

AU (14); GB (60)