Comparison of Insulin Glargine/Insulin Glulisine Regimen to Insulin Aspart/Insulin Aspart Protamine 30/70 in Type 2 Diabetes Mellitus Patients (T2DM) (B to B)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01212913
First received: September 30, 2010
Last updated: July 5, 2013
Last verified: July 2013
  Purpose

Primary Objective:

To demonstrate the non-inferiority of hemoglobin A1c (HbA1c) control at six months between the basal plus one and the biphasic insulin regimen.

Secondary Objective:

To demonstrate favorable outcome for basal plus over biphasic insulin when it comes to comparing when both hemoglobin A1c (HbA1c) target goal achievement and non-hypoglycemic event is taken into account.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: INSULIN GLARGINE
Drug: INSULIN GLULISINE
Drug: Insulin aspart
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 (Insulin Glargine/Insulin Glulisine) Regimen to Biphasic Insulin (InsulinAspart/Insulin Aspart Protamine 30/70) in T2DM Patients Who Require Insulin Intensification After Basal Insulin Optimization.

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Change in hemoglobin A1c level (HbA1c) [ Time Frame: At 6 months of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rate of hypoglycemic events (total, severe, nocturnal) [ Time Frame: from baseline to the study endpoint (over 6 months of treatment) ] [ Designated as safety issue: Yes ]
  • Proportion of patients with HbA1c < 7% [ Time Frame: from baseline to the study endpoint (over 6 months of treatment) ] [ Designated as safety issue: No ]
  • Change in body weight [ Time Frame: from baseline to the study endpoint (over 6 months of treatment) ] [ Designated as safety issue: No ]
  • Reactive Oxidative Stress (ROS) level changes [ Time Frame: from baseline to the study endpoint (over 6 months of treatment) ] [ Designated as safety issue: No ]
  • Change in Quality of Life [ Time Frame: from baseline to the study endpoint (over 6 months of treatment) ] [ Designated as safety issue: No ]
  • Continuous Glucose Monitoring System (CGMS) data [ Time Frame: at baseline, 3 and 6 months ] [ Designated as safety issue: No ]

Enrollment: 161
Study Start Date: August 2010
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: group 1: Basal plus
Insulin glargine with dosage adjustment determined according to the mean value of the last three days Fasting Blood Glucose (FBG) Insulin glulisine, at initial dosing of 4IU, then weekly adjusted according to the mean value of the last three days PostPrandial Blood Glucose (PPBG)
Drug: INSULIN GLARGINE
Pharmaceutical form: solution for injection Route of administration: subcutaneous Dose regimen: once daily
Other Name: Lantus
Drug: INSULIN GLULISINE
Pharmaceutical form: solution for injection Route of administration: subcutaneous Dose regimen: once daily
Other Name: Apidra
Active Comparator: group 2: Biphasic insulin
Insulin aspart/insulin aspart protamine 30/70 (novomix 30) given twice daily and titrated weekly (before breakfast and dinner) according to the lowest of three previous days' pre-meal levels (both breakfast and dinner). Target is 70 mg/dL < Pre-meal blood glucose (dinner and breakfast).
Drug: Insulin aspart
Pharmaceutical form: solution for injection Route of administration: subcutaneous Dose regimen: twice daily
Other Name: NovoMix 30

  Eligibility

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

Inclusion criteria:

  1. Sub-optimally controlled Type 2 Diabetes Mellitus (T2DM) patients treated with insulin glargine for a minimum of 3 months:

    • Sub-optimal: HbA1c level >7% and fasting blood glucose <130mg/dL
  2. Male or Female ≥18 years old
  3. Body Mass Index (BMI) <40
  4. 10% ≥HbA1c ≥7%
  5. If taking Oral anti-diabetics (OADs), must be on stable dose for at least 1 months
  6. Patients willing to sign data release consent form

Exclusion criteria:

  1. Diabetes other than T2DM
  2. Enrolled in other clinical trials
  3. Previous treatment with an insulin other than insulin glargine
  4. Treatment with Glucagon-like peptide-1 (GLP-1) receptor agonists or with Di Peptidyl Peptidase 4 (DPP-IV) inhibitors
  5. Pregnant or lactating women
  6. Contraindicated to Lantus (insulin glargine) / Apidra (insulin glulisine) / Novomix 30 (insulin aspart)
  7. Treatment with systemic corticoid steroids within the last 3 months prior to study enter
  8. Treatment with any investigational product within the last 3 months prior to study entry

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: NCT01212913

Locations
Korea, Republic of
Administrative Office
Seoul, Korea, Republic of
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01212913     History of Changes
Other Study ID Numbers: LANTU_L_04867, U1111-1117-2786
Study First Received: September 30, 2010
Last Updated: July 5, 2013
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Glargine
Insulin aspart, insulin aspart protamine drug combination 30:70
Insulin glulisine
Insulin
Insulin Aspart
Biphasic Insulins
Insulin, Long-Acting
Protamines
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Heparin Antagonists
Molecular Mechanisms of Pharmacological Action
Coagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 18, 2014