Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01838083
Other study ID # PKD13560
Secondary ID 2012-005777-31U1
Status Completed
Phase Phase 1
First received April 16, 2013
Last updated August 9, 2013
Start date April 2013
Est. completion date August 2013

Study information

Verified date August 2013
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority Germany: Ministry of Health
Study type Interventional

Clinical Trial Summary

Primary Objective:

To demonstrate equivalence in exposure to insulin glargine given as test formulation T and reference formulation R in steady state conditions after 6 once-daily subcutaneous (SC) doses

Secondary Objective:

- To assess relative Pharmacodynamic activity of the insulin glargine test formulation T to the insulin glargine reference formulation R in steady state conditions after 6 once-daily SC doses

- To assess the safety and tolerability of the test and reference formulations of two new insulin glargine formulations


Description:

Total study duration per subject: 29 to 64 days including screening visit

Duration of each part of the study for one subject:

- Screening: 3 to 21 days before 1st dosing (Day -21 to Day -3)

- Treatment Period 1 and 2: 8 days (dosing on 6 days)

- Washout between last/1st dosing days of the treatment periods: 7-21 days (preferentially 7 days) End-of-Study Visit: 7-10 days after last dosing


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date August 2013
Est. primary completion date August 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 64 Years
Eligibility Inclusion criteria :

- Male or female subjects, between 18 and 64 years of age, inclusive, with diabetes mellitus type 1 for more than one year

- Total insulin dose of < 1.2 U/kg/day

- Minimum usual basal insulin dose = 0.2 U/kg/day

- Body weight between 50.0 kg and 110.0 kg, Body Mass Index between 18.5 and 30.0 kg/m2 inclusive

- Fasting negative serum C-peptide (< 0.3 nmol/L)

- Glycohemoglobin (HbA1c) = 75 mmol/mol [= 9.0%]

- Stable insulin regimen for at least 2 months prior to inclusion in study

- Certified as otherwise healthy for Type-1 Diabetes mellitus patient

- Laboratory parameters within the normal range

- Women of childbearing potential with negative pregnancy test and use of a highly effective contraceptive method or women with confirmed postmenopausal status

Exclusion criteria:

- Any history or presence of clinically relevant cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic (apart from diabetes mellitus type 1), hematological, neurological, psychiatric, systemic (affecting the body as a whole), ocular, gynecologic (if female), or infectious disease; any acute infectious disease or signs of acute illness.

- More than one episode of severe hypoglycemia with seizure, coma or requiring assistance of another person during the past 6 months

- Frequent severe headaches and / or migraine, recurrent nausea and / or vomiting (more than twice a month)

- Symptomatic hypotension (whatever the decrease in blood pressure), or asymptomatic postural hypotension defined by a decrease in systolic blood pressure equal to or greater than 20 mmHg within three minutes when changing from the supine to the standing position

- Presence or history of a drug allergy or clinically significant allergic disease according to the Investigator's judgment

- Likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol

- Presence or history of drug or alcohol abuse (alcohol consumption > 40 grams / day)

- If female, pregnancy (defined as positive Beta Human Chorionic Gonadotropin test), breast-feeding

- Known hypersensitivity to insulin glargine or excipients of the study drug

- Any history or presence of deep leg vein thrombosis or a frequent appearance of deep leg vein thrombosis in first degree relatives (parents, siblings or children)

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Intervention

Drug:
Insulin glargine new formulation HOE901
Pharmaceutical form: solution Route of administration: subcutaneous

Locations

Country Name City State
Germany Investigational Site Number 276001 Neuss

Sponsors (1)

Lead Sponsor Collaborator
Sanofi

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Area under the serum insulin concentration curve within 24 hours (INS-AUC0-24) after dosing on Day 6 24-hours (D6 to D7) No
Secondary Maximum insulin concentration (INS-Cmax) 24-hours (D6 to D7) No
Secondary Time to INS-Cmax (INS-tmax) 24-hours (D6 to D7) No
Secondary Time to reach 50% of INS-AUC0-24 (T50%-INS-AUC0-24) 24-hours (D6 to D7) No
Secondary Area under the body-weight-standardized Glucose Infusion Rate (GIR) within 24 hours (GIR-AUC0-24h) after dosing on Day 6 during the clamp 24-hours (D6 to D7) No
Secondary Maximum smoothed body weight standardized glucose infusion rate (GIRmax) 24-hours (D6 to D7) No
Secondary Time to GIRmax (GIR-Tmax) 24-hours (D6 to D7) No
Secondary Time to reach at least 50% of GIR-AUC0-24 (T50%-GIR-AUC0-24) 24-hours (D6 to D7) No
Secondary Duration of blood glucose control (time to elevation of smoothed blood glucose profile above clamp level and to elevation above different prespecified blood glucose levels) 24-hours (D6 to D7) No
Secondary Safety as measured by adverse events/serious adverse events, ohypoglycemia events, physical examinations, clinical laboratory, electrocardiograms, vital signs, injection site reactions and anti-insulin antibodies. up to 9 weeks Yes
See also
  Status Clinical Trial Phase
Recruiting NCT05536232 - Residual Insulin Secretion in Patients With Type 1 Diabetes Under a Low Carbohydrate Diet or a Ketogenic Diet N/A
Completed NCT04255381 - Yale-Harvard Hotel-based Closed-Loop Studies in Children (HY-GRAID) N/A
Completed NCT04625595 - Multiple Ascending Dose (MAD) Study of IMT-002 in HLA-DQ8-positive Type 1 Diabetes Phase 1
Active, not recruiting NCT06177691 - Hybrid Closed Loop Therapy and Verapamil for Beta Cell Preservation in New Onset Type 1 Diabetes (CLVer): Extension Study
Completed NCT04002557 - Optimising Consultation Summaries to Promote Good Health
Completed NCT05876273 - Neural-net Artificial Pancreas (NAP) N/A
Withdrawn NCT03236558 - The Role of the Thymus in Type I Diabetes. N/A
Completed NCT03179280 - Effect of Dual-wave Insulin Bolus on Postprandial Glycaemia N/A
Completed NCT06253351 - Real-world Use of Hybrid Closed Loop in Adolescents and Young Adults 15-25 Years of Age With Type 1 Diabetes
Completed NCT01357603 - Comparative Glucose Clamp Study of Wockhardt's Recombinant Insulin Analog Glargine(Glaritus) With Lantus in T1DM Phase 1
Completed NCT04233034 - Hybrid Closed Loop Therapy and Verapamil for Beta Cell Preservation in New Onset Type 1 Diabetes Phase 3
Not yet recruiting NCT06408207 - CGM Academy for Youth With Type 1 Diabetes N/A
Recruiting NCT06408558 - Safe Use of New Technologies in Diabetes in Flight N/A
Active, not recruiting NCT03782636 - Interleukin-2 Therapy of Autoimmunity in Diabetes (ITAD) Phase 2
Completed NCT04520971 - Closed-loop Insulin Delivery in Pregnant Women With Type 1 Diabetes N/A
Recruiting NCT05766657 - Evaluation of an Anti-inflammatory Diet in Autoimmune and Metabolic Diseases N/A