Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 1 Diabetes Mellitus on Basal Plus Mealtime Insulin

NCT01658579 | Completed Phase 2 Results

• 2 other identifiers: PDY12777U1111-1130-3593
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 3

Brief Summary

Primary Objective:

• To compare the glucose control during treatment with a new formulation of insulin glargine and Lantus in adult participants with type 1 diabetes mellitus Secondary Objectives:
• To compare a new formulation of insulin glargine and Lantus given in the morning or in the evening
• To compare the incidence and frequency of hypoglycemic episodes
• To assess the safety and tolerability of the new formulation of insulin glargine

Conditions

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Percentage of Time in Target Plasma Glucose Range (4.4-7.8 mmol/L [80-140 mg/dL])

  Percentage of time with glucose within glycemic range (4.4-7.8 mmol/L) was assessed by the total time within glycemic range divided by the length of the assessment interval.

  Up to Week 16 (assessed at Weeks 7-8 in Period A and Weeks 15-16 in Period B)

Secondary Outcomes (9)

• Percentage of Time Above the Upper Limit of Glycemic Range (Greater Than [>] 7.8 mmol/L [(140 mg/dL])

  Up to Week 16 (assessed at Weeks 7-8 in Period A and Weeks 15-16 in Period B)

• Percentage of Time Below The Lower Limit of Glycemic Range (<4.4 mmol/L [80 mg/dL])

  Up to Week 16 (assessed at Weeks 7-8 in Period A and Weeks 15-16 in Period B)

• Evaluation of Diurnal Glucose Exposure, Variability, and Stability

  Up to Week 16 (assessed at Weeks 7-8 in Period A and Weeks 15-16 in Period B)

• Percentage of Time in Target Plasma Glucose Range (4.4-7.8 mmol/L [80-140 mg/dL]) in the Last Four Hours of Each Dosing Interval at Weeks 7 and 8 in Period A and Weeks 15 and 16 in Period B

  Weeks 7-8 in Period A and Weeks 15-16 in Period B

• Change in HbA1c From Baseline to Week 8 and 16

  Baseline, Week 8, 16

Study Arms (4)

HOE901-U300 Morning Then Evening

EXPERIMENTAL

HOE901-U300 (new insulin glargine 300 units per milliliter \[U/mL\]) subcutaneous (SC) injection once daily in morning for 8 weeks during treatment period A, followed by once daily in evening for 8 weeks during treatment period B. Dose titration seeking fasting plasma glucose 4.4-7.2 millimole per liter (mmol/L).

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

HOE901-U300 Evening Then Morning

EXPERIMENTAL

HOE901-U300 (new insulin glargine 300 U/mL) SC injection once daily in evening for 8 weeks during treatment period A, followed by once daily in morning for 8 weeks during treatment period B. Dose titration seeking fasting plasma glucose 4.4-7.2 mmol/L.

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

Lantus Morning Then Evening

ACTIVE COMPARATOR

Lantus (HOE901-U100, insulin glargine 100 U/mL) SC injection once daily in morning for 8 weeks during treatment period A, followed by once daily in evening for 8 weeks during treatment period B. Dose titration seeking fasting plasma glucose 4.4-7.2 mmol/L.

Drug: Lantus (insulin glargine)

Lantus Evening Then Morning

ACTIVE COMPARATOR

Lantus (HOE901-U100, insulin glargine 100 U/mL) SC injection once daily in evening for 8 weeks during treatment period A, followed by once daily in morning for 8 weeks during treatment period B. Dose titration seeking fasting plasma glucose 4.4-7.2 mmol/L.

Drug: Lantus (insulin glargine)

Interventions

HOE901-U300 (new formulation of insulin glargine) DRUG

HOE901-U300 Evening Then Morning; HOE901-U300 Morning Then Evening

Lantus (insulin glargine) DRUG

Lantus Evening Then Morning; Lantus Morning Then Evening

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants with Type 1 diabetes mellitus

You may not qualify if:

• HbA1c greater than (\>) 9% (at screening)
• Participants receiving \>0.5 U/kg body weight basal insulin in the last 30 days prior to screening visit
• Participants not on stable insulin dose (+/- 20% total basal insulin dose) in the last 30 days prior to screening visit
• Less than 1 year on any basal plus mealtime insulin
• Participants using pre-mix insulins, human regular insulin as mealtime insulin and/or any antidiabetic drugs other than basal insulin and mealtime analogue insulin in the last 3 months before screening visit
• Use of an insulin pump in the last 6 months before screening visit;
• Any contraindication to use of insulin glargine as defined in the national product label
• Not willing to inject insulin glargine as assigned by the randomization process once daily in the morning or evening
• Hospitalization for diabetic ketoacidosis or history of severe hypoglycemia (requiring 3rd party assistance) in the last 6 months prior to randomization
• Initiation of any glucose-lowering agents in the last 3 months before screening visit
• Weight change of greater than equal to (\>=) 5 kg during the last 3 months prior to screening visit
• Unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema likely to require laser, surgical treatment or injectable drugs during the study period
• The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (3)

Investigational Site Number 840002

Temecula, California, 92591, United States

Location

Investigational Site Number 840001

Minneapolis, Minnesota, 55416, United States

Location

Investigational Site Number 840003

Portland, Oregon, 97201-3098, United States

Location

Related Publications (1)

• Bergenstal RM, Bailey TS, Rodbard D, Ziemen M, Guo H, Muehlen-Bartmer I, Ahmann AJ. Comparison of Insulin Glargine 300 Units/mL and 100 Units/mL in Adults With Type 1 Diabetes: Continuous Glucose Monitoring Profiles and Variability Using Morning or Evening Injections. Diabetes Care. 2017 Apr;40(4):554-560. doi: 10.2337/dc16-0684. Epub 2017 Jan 23.

  PMID: 28115474 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulin Glargine

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Trial Transparency Team
• Organization: Sanofi

Contact--US@sanofi.com

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2012
• First Posted: August 7, 2012
• Study Start: August 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: June 1, 2015
• Results First Posted: May 7, 2015

Record last verified: 2015-05

Locations

US (3)