Type 2 Diabetes MellitusPhase 1NCT01159353
Pharmacodynamic and Pharmacokinetic Effects of Insulin Glulisine in Obese Subjects With Type 2 Diabetes After a Standard Meal in Comparison to Insulin Aspart
A Phase 1 study testing Insulin glulisine and Insulin aspart in people with Type 2 Diabetes Mellitus, run by Sanofi at 1 site in France.
Trial summary
Primary Objective: To assess the effect of insulin glulisine on the post-prandial plasma glucose excursion during the first hour after a standard meal in comparison to insulin aspart in obese subjects with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Insulin glulisine and Insulin aspart
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2007to Apr 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with type 2 diabetes for at least one year
- treated with oral antidiabetic agents (OADs) for at least 6 months
- Baseline C-peptide ≥0.1 nmol/L
- BMI (body mass index) between 30 and 40 kg/m2
- HbA1c (glycosylated hemoglobin) < 8.5%
- signed informed consent
Who cannot join
- type I diabetes mellitus
- current treatment with insulin
- pregnant and breast-feeding women
- any medication known to influence insulin sensitivity
- current treatment with systemic corticosteroids
- history of acute metabolic complications in the past 3 months
Show all 13Show fewer
- recurrent severe hypoglycaemia or hypoglycaemic unawareness
- active proliferative diabetic retinopathy and known diabetic gastroparesis
- impaired hepatic function, as shown but not limited to ALT or AST above 2 times the upper limit of normal
- clinically relevant illness such as nephropathy and impaired renal function as shown by clearance < 30 ml/min
- any history or presence of clinically relevant abnormality, medical condition (cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, hematological, neurologic, psychiatric, systemic, ocular or infectious disease; any acute infectious disease or signs of acute illness making implementation of the protocol or interpretation of the results difficult
- hypersensitivity to insulins or insulin analogs
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double Blind Study to Assess the Pharmacodynamic and Pharmacokinetic Effects of Insulin Glulisine in Obese Subjects With Type 2 Diabetes After a Standard Meal in Comparison to Insulin Aspart
Primary Objective:
- To assess the effect of insulin glulisine on the post-prandial plasma glucose excursion during the first hour after a standard meal in comparison to insulin aspart in obese subjects with type 2 diabetes.
Secondary Objectives:
Pharmacodynamic objectives:
- To assess the effect of insulin glulisine on the postprandial plasma glucose excursion during 6 hours after a standard meal in comparison to insulin aspart.
Pharmacokinetic objective:
- To assess post-prandial plasma insulin excursion after a standard meal, in each treatment groups
Safety objective:
- To assess the safety of insulin glulisine in comparison to insulin aspart
Read the detailed description
Duration of treatment: two study days separated by a 7-day wash-out period
Duration of observation:
- screening period of 1-2 weeks, >2 study days (with a wash-out period of 7 days between the study days),
- Follow-up visit (within 2 weeks after the end of the study treatment period).
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Insulin glulisine, Insulin aspart
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin glulisineDrug
Also called Apidra
Insulin glulisine 100 U/ml, solution for injection in vial Dose: 0.2 U/Kg Administration: single subcutaneous injection with syringe in the periumbilical abdomen within 2 minutes before the standard meal
Insulin aspartDrug
Also called NovoRapid
Insulin aspart: 100 U/mL, solution for injection in vial Dose: 0.2 U/Kg Administration: single subcutaneous injection with syringe in the periumbilical abdomen within 2 minutes before the standard meal
| Study group | Role | What they receive |
|---|---|---|
| insulin glulisine + insulin aspart | Experimental | insulin glulisine (1 day) + wash-out (7 days) + insulin aspart (1 day) Receives: Drug: Insulin glulisine; Drug: Insulin aspart |
| insulin aspart + insulin glulisine | Experimental | insulin glulisine (1 day) + wash-out (7 days) + insulin aspart (1 day) Receives: Drug: Insulin glulisine; Drug: Insulin aspart |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma glucose concentration curve (AUC) between 0 and 1 hour after insulin injection AUC(0-1h)
Measured: At day 1 of each treatment period
Secondary outcomes (16)
Area under the curve of plasma glucose concentration AUC(0-2h)
Measured: At day 1 of each treatment period
Area under the curve of plasma glucose concentration AUC(0-4h)
Measured: At day 1 of each treatment period
Area under the curve of plasma glucose concentration AUC(0-6h)
Measured: At day 1 of each treatment period
Delta plasma glucose at 1h after standard meal
Measured: At day 1 of each treatment period
Maximum glucose concentration (GLU max)
Measured: At day 1 of each treatment period
Maximum glucose excursion (delta GLU max)
Measured: At day 1 of each treatment period
Time to delta GLU max
Measured: At day 1 of each treatment period
Time to fraction of total glucose AUC(10%, 20%)
Measured: At day 1 of each treatment period
Area under the plasma insulin concentration curve AUC (0-1h)
Measured: At day 1 of each treatment period
Area under the plasma insulin concentration curve AUC (0-2h)
Measured: At day 1 of each treatment period
Area under the plasma insulin concentration curve AUC (0-4h)
Measured: At day 1 of each treatment period
Area under the plasma insulin concentration curve AUC (0-6h)
Measured: At day 1 of each treatment period
Maximum insulin concentration (Cmax)
Measured: At day 1 of each treatment period
Time to fraction of total insulin AUC (10%, 20%)
Measured: At day 1 of each treatment period
Time to Cmax
Measured: At day 1 of each treatment period
Hypoglycaemia and adverse events
Measured: from randomization to the end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2010 (estimated)
- Study startSep 2007
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01159353
- Sponsor's protocol ID
- APIDR_C_01160
- Other IDs
- 2006-005536-24
- Status last verified
- Jul 2010
- First submitted
- 8 Jul 2010
- Last updated
- 16 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind Study to Assess the Pharmacodynamic and Pharmacokinetic Effects of Insulin Glulisine in Obese Subjects With Type 2 Diabetes After a Standard Meal in Comparison to Insulin Aspart
- ClinicalTrials.gov ID
- NCT01159353
- Acronym / sponsor ID
- APIDR_C_01160
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 9 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Objective:
- To assess the effect of insulin glulisine on the post-prandial plasma glucose excursion during the first hour after a standard meal in comparison to insulin aspart in obese subjects with type 2 diabetes.
Secondary Objectives:
Pharmacodynamic objectives:
- To assess the effect of insulin glulisine on the postprandial plasma glucose excursion during 6 hours after a standard meal in comparison to insulin aspart.
Pharmacokinetic objective:
- To assess post-prandial plasma insulin excursion after a standard meal, in each treatment groups
Safety objective:
- To assess the safety of insulin glulisine in comparison to insulin aspart
Detailed description
Duration of treatment: two study days separated by a 7-day wash-out period
Duration of observation:
- screening period of 1-2 weeks, >2 study days (with a wash-out period of 7 days between the study days),
- Follow-up visit (within 2 weeks after the end of the study treatment period).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| insulin glulisine + insulin aspart | Experimental | Drug: Insulin glulisine, Drug: Insulin aspartinsulin glulisine (1 day) + wash-out (7 days) + insulin aspart (1 day) |
| insulin aspart + insulin glulisine | Experimental | Drug: Insulin glulisine, Drug: Insulin aspartinsulin glulisine (1 day) + wash-out (7 days) + insulin aspart (1 day) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- patients with type 2 diabetes for at least one year
- treated with oral antidiabetic agents (OADs) for at least 6 months
- Baseline C-peptide ≥0.1 nmol/L
- BMI (body mass index) between 30 and 40 kg/m2
- HbA1c (glycosylated hemoglobin) < 8.5%
Key exclusion criteria (13 listed)
- type I diabetes mellitus
- current treatment with insulin
- pregnant and breast-feeding women
- any medication known to influence insulin sensitivity
- current treatment with systemic corticosteroids
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insulin glulisineAlso: ApidraInsulin glulisine 100 U/ml, solution for injection in vial Dose: 0.2 U/Kg Administration: single subcutaneous injection with syringe in the periumbilical abdomen within 2 minutes before the standard meal | Drug | insulin aspart + insulin glulisine, insulin glulisine + insulin aspart |
| Insulin aspartAlso: NovoRapidInsulin aspart: 100 U/mL, solution for injection in vial Dose: 0.2 U/Kg Administration: single subcutaneous injection with syringe in the periumbilical abdomen within 2 minutes before the standard meal | Drug | insulin aspart + insulin glulisine, insulin glulisine + insulin aspart |
Primary outcome
Area under the plasma glucose concentration curve (AUC) between 0 and 1 hour after insulin injection AUC(0-1h)
Time frame: At day 1 of each treatment period
16 secondary outcomes
Area under the curve of plasma glucose concentration AUC(0-2h)
Time frame: At day 1 of each treatment period
Area under the curve of plasma glucose concentration AUC(0-4h)
Time frame: At day 1 of each treatment period
Area under the curve of plasma glucose concentration AUC(0-6h)
Time frame: At day 1 of each treatment period
Delta plasma glucose at 1h after standard meal
Time frame: At day 1 of each treatment period
Maximum glucose concentration (GLU max)
Time frame: At day 1 of each treatment period
Maximum glucose excursion (delta GLU max)
Time frame: At day 1 of each treatment period
Time to delta GLU max
Time frame: At day 1 of each treatment period
Time to fraction of total glucose AUC(10%, 20%)
Time frame: At day 1 of each treatment period
Area under the plasma insulin concentration curve AUC (0-1h)
Time frame: At day 1 of each treatment period
Area under the plasma insulin concentration curve AUC (0-2h)
Time frame: At day 1 of each treatment period
Area under the plasma insulin concentration curve AUC (0-4h)
Time frame: At day 1 of each treatment period
Area under the plasma insulin concentration curve AUC (0-6h)
Time frame: At day 1 of each treatment period
Maximum insulin concentration (Cmax)
Time frame: At day 1 of each treatment period
Time to fraction of total insulin AUC (10%, 20%)
Time frame: At day 1 of each treatment period
Time to Cmax
Time frame: At day 1 of each treatment period
Hypoglycaemia and adverse events
Time frame: from randomization to the end of study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2010.
Related trials for Type 2 Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Insulin glulisine and Insulin aspart in people with Type 2 Diabetes Mellitus, run by Sanofi at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the plasma glucose concentration curve (AUC) between 0 and 1 hour after insulin injection AUC(0-1h) (time frame: At day 1 of each treatment period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2010.