Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes on Basal Insulin With Oral Antidiabetic Therapy

• Register: ClinicalTrials.gov
• Last refreshed on: 28 March 2022
• Main ID: NCT01499095
• Date of registration: 16/12/2011
• Prospective Registration: No
• Primary sponsor: Sanofi
• Public title: Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes on Basal Insulin With Oral Antidiabetic Therapy EDITION II
• Scientific title: 6-Month, Multicenter, Randomized, Open-label, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus® Both in Combination With Oral Antihyperglycemic Drug(s) in Patients With Type 2 Diabetes Mellitus With a 6-month Safety Extension Period
• Date of first enrolment: December 2011
• Target sample size: 811
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01499095
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Canada, Chile, Finland, France, Germany, Hungary, Mexico, Portugal, Romania, Russian Federation, South Africa, Spain, United States

Contacts

• Name: Clinical Sciences & Operations
• Affiliation: Sanofi

Key inclusion & exclusion criteria

Inclusion criteria :

- Participants with type 2 diabetes mellitus

- Substudy inclusion criteria:

- Completion of the 6-month study period in main study (Visit 10)

- Randomized and treated with insulin glargine new formulation during the 6- month
treatment period (Baseline - Month 6)

Exclusion criteria:

- Age less than (<) 18 years

- HbA1c <7.0% or greater than (>) 10% at screening

- Diabetes other than type 2 diabetes mellitus

- Less than 6 months on basal insulin treatment together with oral antihyperglycemic
drug(s) and self-monitoring of blood glucose

- Participants using sulfonylurea in the last 2 months before screening visit

- Any contraindication to use of insulin glargine as defined in the national product
label

- Use of insulin pump in the last 6 months before screening

- Initiation of new glucose-lowering medications in the last 3 months before screening
visit

- History or presence of significant diabetic retinopathy or macular edema likely to
require laser or injectable drugs or surgical treatment during the study period

- Pregnant or breast-feeding women or women who intend to become pregnant during the
study period

- Substudy exclusion criteria:

- Participant not willing to use the adaptable injection intervals on at least two
days per week

The above information is not intended to contain all considerations relevant to a
participant's potential participation in a clinical trial.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Type 2 Diabetes Mellitus

Intervention(s)

Drug: Lantus (Insulin glargine)

Drug: HOE901-U300 (new formulation of insulin glargine)

Primary Outcome(s)

Change in HbA1c From Baseline to Month 6 Endpoint [Time Frame: Baseline, Month 6]

Secondary Outcome(s)

Change in 8-Point SMPG Profiles Per Time Point From Baseline to Month 6 Endpoint [Time Frame: Baseline, Month 6]

Change in Average Preinjection Self-Monitored Plasma Glucose (SMPG) From Baseline to Month 6 Endpoint [Time Frame: Baseline, Month 6]

Percentage of Participants With At Least One Severe and/or Confirmed Nocturnal Hypoglycemia From Start of Week 9 to Month 6 Endpoint [Time Frame: Week 9 Up to Month 6]

Percentage of Participants With HbA1c <7% at Month 6 Endpoint [Time Frame: Month 6]

Change in Fasting Plasma Glucose (FPG) From Baseline to Month 6 Endpoint [Time Frame: Baseline, Month 6]

Change in Variability of Preinjection SMPG From Baseline to Month 6 Endpoint [Time Frame: Baseline, Month 6]

Change in Treatment Satisfaction Score Using The Diabetes Treatment Satisfaction Questionnaire (DTSQs) From Baseline to Month 6 Endpoint [Time Frame: Baseline, Month 6]

Change in Daily Basal Insulin Dose From Baseline to Month 6 Endpoint [Time Frame: Baseline, Month 6]

Percentage of Participants With FPG <5.6 mmol/L (<100 mg/dL) at Month 6 Endpoint [Time Frame: Month 6]

Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline to Month 12 [Time Frame: Up to Month 12]

Secondary ID(s)

EFC11629

U1111-1118-6943

2010-023770-39

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 23/04/2015
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01499095