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CompletedNCT00310297Updated Jan 11, 2011

Insulin Glulisine in Type 2 Diabetes Mellitus

A Phase 1 interventional study of Insulin Glulisine in Type 2 Diabetes Mellitus, sponsored by Sanofi. Completed. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2011-01-11.

Sponsored by Sanofi · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

Primary objective:

To compare the pharmacodynamics of insulin glulisine and insulin lispro injected subcutaneously before three 500 kcal standard meals during a 12 hour day, in obese subjects with type 2 diabetes.

Secondary objectives:

  • To compare the pharmacokinetics of insulin glulisine and insulin lispro in obese subjects with type 2 diabetes, injected subcutaneously before three standard meals during a 12-hour day.
  • The safety of insulin glulisine, the relationship of the pharmacodynamics and pharmacokinetics with skin thickness and C-peptide, non-esterified fatty acid, triglyceride and β-hydroxybutyrate levels in these subjects will also be assessed.
02

Conditions studied

  • Type 2 Diabetes Mellitus
03

In context

Diabetes Mellitus, Type 2

9,589 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,332 are open to participants now.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Sanofi is the lead sponsor of 1,547 studies on the registry; 88 are open to participants now.

Of its 204 completed or terminated interventional studies of FDA-regulated products, 122 (60%) have results posted.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Type 2 diabetes mellitus
  • Body mass index (BMI) between 35 and 40 kg/m2
  • HbA1c ≤10%
  • Plasma C-peptide levels ≥0.1 nmol/L.
  • Female subjects have to either be postmenopausal, surgically sterilized, or not pregnant and using approved methods of contraception.

Exclusion criteria

Exclusion criteria :

  • Type 1 diabetes mellitus, as defined by the World Health Organization
  • Subjects currently taking any insulin
  • History of hypoglycaemic unawareness
  • Injection site skin thickness \< or = 8 mm

  • Contra-indications from

    • The medical history and physical examination
    • Laboratory tests (haematology, clinical chemistry, and urinalysis by dipstick)
    • Blood pressure and pulse
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)

Interventions

06

What researchers measure

Primary outcomes

  1. Maximum plasma glucose concentration (GLUmax, mmol/L)

    Time frame: During the Study Conduct

  2. Maximum plasma glucose excursion (baseline subtracted glucose concentration, ΔGLUmax, mmol/L)

    Time frame: during the study conduct

  3. Time to GLUmax (Tmax, min)

    Time frame: during the study conduct

Secondary outcomes

  1. Area under the insulin concentration-time curve after injection(μIU.min/mL)

    Time frame: between 0 h and 1 h (AUC0-1h), 0 h and 1.5 h (AUC0-1.5h), 0 h and 2 h (AUC0-2h) and 0 h and 4 h (AUC0-4h)

  2. Maximum concentration (Cmax, μIU/mL)

    Time frame: During the study conduct

  3. Adverse events collection

    Time frame: from the inform consnet signed up to the end of the study

  4. Time to maximum concentration (Tmax, min)

    Time frame: During the study conduct

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Nov 2004 and a primary completion of Dec 2004. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 2, 2006
First posted
Apr 3, 2006
Start
Nov 2004
Primary completionActual
Dec 2004
Last update
Jan 11, 2011
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 11, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00310297
Lead sponsor
Sanofi
First posted
Apr 3, 2006
Start date
Nov 2004
Primary completion
Dec 2004
Last update
Jan 11, 2011

Study contacts

Valérie Pilorget, MD
study director · Sanofi
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2008. You cannot join it, but the record below documents what was studied.

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Discussion

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