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

NCT01079364 | Terminated Phase 4

• 2 other identifiers: APIDR_L_047172009-015742-34
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

• Glycosylated Haemoglobin (HbA1c) Value

  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.

  at screening (week - 2), week 12 (if available) and 24

• Self Measured Blood Glucose (SMBG)

  at Baseline (week 0), week 2, 12 and 24

Secondary Outcomes (5)

• DTSQs (Diabetes Treatment Satisfaction Questionnaire - status)

  at week 0, 12 and 24

• DTSQc (Diabetes Treatment Satisfaction Questionnaire - change)

  at week 24

• ITSQ (Insulin Treatment Satisfaction Questionnaire)

  at week 0, 12 and 24

• Hypoglycemic events

  at week 0, 2, 12 and 24

• Adverse Events (excluding hypoglycemic events)

  at week - 2, 0, 2, 12 and 24

Study Arms (2)

Insulin glargine + Insulin glulisine

EXPERIMENTAL

Daily injection of insulin glargine plus one injection of mealtime insulin glulisine at the main meal

Drug: Insulin glulisine; Drug: Insulin glargine

Premixed insulin

ACTIVE COMPARATOR

twice daily premixed insulin (before breakfast and evening meal).

Drug: Premixed insulin (Insulin Aspart 30/70 )

Interventions

Insulin glulisine DRUG

Pharmaceutical form: boxes of 5 SoloStar® pens Route of administration: injection Dose regimen: once a day

Also known as: Apidra®

Insulin glargine + Insulin glulisine

Insulin glargine DRUG

Pharmaceutical form: boxes of 5 SoloStar® pens Route of administration: injection Dose regimen: once a day

Also known as: Lantus®

Insulin glargine + Insulin glulisine

Premixed insulin (Insulin Aspart 30/70 ) DRUG

Pharmaceutical form:boxes of 5 FlexPens Route of administration: Injection Dose regimen: twice daily

Also known as: NovoMix 30/70®

Premixed insulin

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis Administrative Office

Gouda, Netherlands

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

insulin glulisine; Insulin Glargine; 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

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: February 25, 2010
• First Posted: March 3, 2010
• Study Start: January 1, 2010
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: May 29, 2013

Record last verified: 2013-05

Locations

NL (1)