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OpenTrials
Completed

NCT Number: NCT01212913

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Administrative Office

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • 10% ≥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

Exclusion criteria

  • 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.

Treatment and study plan

insulin glargine

Drug

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

Other names: Lantus

insulin glulisine

Drug

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

Other names: Apidra

insulin aspart

Drug

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

Other names: NovoMix 30

Primary outcomes

  1. Change in hemoglobin A1c level (HbA1c)

    Time frame: At 6 months of treatment

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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.

Acronym: B to B

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Oct 1, 2010
Registry last updated
Jul 8, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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