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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00965549
First received: August 24, 2009
Last updated: January 7, 2013
Last verified: January 2013
  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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Glycosylated Haemoglobin (HbA1c) [ Time Frame: At week 7 and week 32 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00965549

  Show 74 Study Locations
Sponsors and Collaborators
Sanofi
Investigators
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
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Biphasic Insulins
Glargine
Insulin
Insulin Aspart
Insulin glulisine
Insulin, Globin Zinc
Insulin, Long-Acting
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 22, 2014