Better Acceptance of Single Injection Apidra Added to Once Daily Lantus Versus Twice Daily Premixed Insulin in Real Life Use Setting (BASAAL PLUS)

This study has been terminated.
(Slow recruitment)
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01079364
First received: February 25, 2010
Last updated: May 27, 2013
Last verified: May 2013
  Purpose

Primary Objective:

To demonstrate non-inferiority of once daily injection of insulin glargine (Lantus) plus one injection of mealtime insulin glulisine (Apidra) at the main meal versus twice daily premixed insulin (NovoMix 30/70) based on the reduction of HbA1c percentage from baseline to endpoint.

Secondary Objective:

  • To determine treatment satisfaction (DTSQs/Diabetes Treatment Questionnaire - Status, DTSQc/ Diabetes Treatment Questionnaire - change and ITSQ/Insulin Treatment Satisfaction Questionnaire)
  • To determine the mean HbA1c, FBG (Fasting Blood Glucose), prandial BG (Blood Glucose) and proportion of patients with a HbA1c <7%
  • To determine the effect on adverse events (e.g. symptomatic hypoglycemic events, weight gain and injection site reactions)
  • To determine the total insulin dose, average insulin glargine, insulin glulisine and premixed insulin dosages.

Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Insulin glulisine
Drug: Insulin glargine
Drug: Premixed insulin (Insulin Aspart 30/70 )
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: Better Acceptance of a Single Injection Apidra (Insulin Glulisine) Added to Once Daily Lantus (Insulin Glargine) Versus Twice Daily Premixed Insulin in a Real Life Use Setting

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Glycosylated Haemoglobin (HbA1c) Value [ Time Frame: at screening (week - 2), week 12 (if available) and 24 ] [ Designated as safety issue: No ]
    Glycosylated Haemoglobin (HbA1c) is a biological parameter that reflects the blood glucose concentration over a long period of time. It is the standard parameter for glycemic control follow -up in diabetic patients.

  • Self Measured Blood Glucose (SMBG) [ Time Frame: at Baseline (week 0), week 2, 12 and 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • DTSQs (Diabetes Treatment Satisfaction Questionnaire - status) [ Time Frame: at week 0, 12 and 24 ] [ Designated as safety issue: No ]
  • DTSQc (Diabetes Treatment Satisfaction Questionnaire - change) [ Time Frame: at week 24 ] [ Designated as safety issue: No ]
  • ITSQ (Insulin Treatment Satisfaction Questionnaire) [ Time Frame: at week 0, 12 and 24 ] [ Designated as safety issue: No ]
  • Hypoglycemic events [ Time Frame: at week 0, 2, 12 and 24 ] [ Designated as safety issue: No ]
  • Adverse Events (excluding hypoglycemic events) [ Time Frame: at week - 2, 0, 2, 12 and 24 ] [ Designated as safety issue: No ]

Enrollment: 52
Study Start Date: January 2010
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Insulin glargine + Insulin glulisine
Daily injection of insulin glargine plus one injection of mealtime insulin glulisine at the main meal
Drug: Insulin glulisine
Pharmaceutical form: boxes of 5 SoloStar® pens Route of administration: injection Dose regimen: once a day
Other Name: Apidra®
Drug: Insulin glargine
Pharmaceutical form: boxes of 5 SoloStar® pens Route of administration: injection Dose regimen: once a day
Other Name: Lantus®
Active Comparator: Premixed insulin
twice daily premixed insulin (before breakfast and evening meal).
Drug: Premixed insulin (Insulin Aspart 30/70 )
Pharmaceutical form:boxes of 5 FlexPens Route of administration: Injection Dose regimen: twice daily
Other Name: NovoMix 30/70®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Patients with type 2 diabetes mellitus treated with insulin glargine once daily and oral blood glucose lowering medication
  • Patients with a HbA1c > 7%
  • Patients with a FBG within range (4-7 mmol/L) at baseline, based on the mean of 3 FBG values (measured 5x during the run-in phase, with the highest and lowest value excluded)

Exclusion criteria:

  • Patients treated with an insulin other than insulin glargine
  • Patients with hypersensitivity to insulin glargine, insulin glulisine, biphasic insulin aspart/insulin aspart protamine 30/70 or any of the excipients
  • Patients with a (pre)proliferative retinopathy (an optic fundus examination should have been performed within the 2 years prior to study entry)
  • Pregnant or lactating women
  • Patients who are unable to fill in the PRO (Patient Reported Outcomes) questionnaires

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: NCT01079364

Locations
Netherlands
Sanofi-Aventis Administrative Office
Gouda, Netherlands
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01079364     History of Changes
Other Study ID Numbers: APIDR_L_04717, 2009-015742-34
Study First Received: February 25, 2010
Last Updated: May 27, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Glargine
Insulin glulisine
Insulin
Insulin, Long-Acting
Insulin Aspart
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014