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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)

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ClinicalTrials.gov Identifier: NCT01212913
Recruitment Status : Completed
First Posted : October 1, 2010
Last Update Posted : July 8, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: INSULIN GLARGINE Drug: INSULIN GLULISINE Drug: Insulin aspart Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 161 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : August 2010
Primary Completion Date : May 2012
Study Completion Date : May 2012


Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Change in hemoglobin A1c level (HbA1c) [ Time Frame: At 6 months of treatment ]

Secondary Outcome Measures :
  1. Rate of hypoglycemic events (total, severe, nocturnal) [ Time Frame: from baseline to the study endpoint (over 6 months of treatment) ]
  2. Proportion of patients with HbA1c < 7% [ Time Frame: from baseline to the study endpoint (over 6 months of treatment) ]
  3. Change in body weight [ Time Frame: from baseline to the study endpoint (over 6 months of treatment) ]
  4. Reactive Oxidative Stress (ROS) level changes [ Time Frame: from baseline to the study endpoint (over 6 months of treatment) ]
  5. Change in Quality of Life [ Time Frame: from baseline to the study endpoint (over 6 months of treatment) ]
  6. Continuous Glucose Monitoring System (CGMS) data [ Time Frame: at baseline, 3 and 6 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01212913


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01212913     History of Changes
Other Study ID Numbers: LANTU_L_04867
U1111-1117-2786 ( Other Identifier: WHO )
First Posted: October 1, 2010    Key Record Dates
Last Update Posted: July 8, 2013
Last Verified: July 2013

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