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

NCT01212913 | Completed Phase 4

• 2 other identifiers: LANTU_L_04867U1111-1117-2786
• Study Type: interventional
• Target: 161
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Change in hemoglobin A1c level (HbA1c)

  At 6 months of treatment

Secondary Outcomes (6)

• Rate of hypoglycemic events (total, severe, nocturnal)

  from baseline to the study endpoint (over 6 months of treatment)

• Proportion of patients with HbA1c < 7%

  from baseline to the study endpoint (over 6 months of treatment)

• Change in body weight

  from baseline to the study endpoint (over 6 months of treatment)

• Reactive Oxidative Stress (ROS) level changes

  from baseline to the study endpoint (over 6 months of treatment)

• Change in Quality of Life

  from baseline to the study endpoint (over 6 months of treatment)

Study Arms (2)

group 1: Basal plus

EXPERIMENTAL

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; Drug: INSULIN GLULISINE

group 2: Biphasic insulin

ACTIVE COMPARATOR

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

Interventions

INSULIN GLARGINE DRUG

Pharmaceutical form: solution for injection Route of administration: subcutaneous Dose regimen: once daily

Also known as: Lantus

group 1: Basal plus

INSULIN GLULISINE DRUG

Pharmaceutical form: solution for injection Route of administration: subcutaneous Dose regimen: once daily

Also known as: Apidra

group 1: Basal plus

Insulin aspart DRUG

Pharmaceutical form: solution for injection Route of administration: subcutaneous Dose regimen: twice daily

Also known as: NovoMix 30

group 2: Biphasic insulin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Male or Female ≥18 years old
• Body Mass Index (BMI) \<40
• % ≥HbA1c ≥7%
• If taking Oral anti-diabetics (OADs), must be on stable dose for at least 1 months
• Patients willing to sign data release consent form

You may not qualify if:

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

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Administrative Office

Seoul, South Korea

Location

Related Publications (1)

• Jin SM, Kim JH, Min KW, Lee JH, Ahn KJ, Park JH, Jang HC, Park SW, Lee KW, Won KC, Kim YI, Chung CH, Park TS, Lee JH, Lee MK. Basal-prandial versus premixed insulin in patients with type 2 diabetes requiring insulin intensification after basal insulin optimization: A 24-week randomized non-inferiority trial. J Diabetes. 2016 May;8(3):405-13. doi: 10.1111/1753-0407.12312. Epub 2015 Jun 29.

  PMID: 25952532 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Glargine; insulin glulisine; Insulin Aspart; insulin aspart, insulin aspart protamine drug combination 30:70

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Insulin, Short-Acting

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2010
• First Posted: October 1, 2010
• Study Start: August 1, 2010
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: July 8, 2013

Record last verified: 2013-07

Locations

KR (1)