Comparison of a Basal Plus One Insulin Regimen With a Biphasic Insulin Regimen in Type 2 Diabetes Patients (LanScape)
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus, Type 2 |
Drug: INSULIN GLARGINE (HOE901) Drug: Insulin aspart Drug: Insulin Glulisine |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
- Glycosylated Haemoglobin (HbA1c) [ Time Frame: At week 7 and week 32 ] [ Designated as safety issue: No ]
- Weight [ Time Frame: At week 8 and week 32 ] [ Designated as safety issue: No ]
- 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) [ Time Frame: Week 8 and week 32 ] [ Designated as safety issue: No ]
- Hypoglycaemia (total, severe and nocturnal) [ Time Frame: At week 0 and week 32 ] [ Designated as safety issue: No ]
| Enrollment: | 463 |
| Study Start Date: | July 2009 |
| Study Completion Date: | December 2012 |
| Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Lantus + Apidra basal plus one
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)
LANTUS®: Solution for injection. 100U/mL in a prefilled pen (SoloStar®)
Drug: Insulin Glulisine
APIDRA®: Solution for injection. 100U/mL in a prefilled pen (SoloStar®)
|
|
Active Comparator: NovoMix 30 Biphasic
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
NovoMix® 30: Suspension for injection. 100U/mL in a prefilled pen (FlexPen®)
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Show 74 Study Locations| Study Director: | Christine van Schalkwyk, MD | Sanofi |
More Information
No publications provided
| Responsible Party: | Sanofi |
| ClinicalTrials.gov Identifier: | NCT00965549 History of Changes |
| Other Study ID Numbers: | LANTU_L_04211, 2008-007026-19(EudraCT) |
| Study First Received: | August 24, 2009 |
| Last Updated: | January 7, 2013 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Insulin aspart Glargine |
Insulin glulisine Insulin Insulin, Long-Acting Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013