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Diabetes Mellitus, Type 2Phase 4NCT00553020

Assessment of Duration of Metabolic Effect of a Single Bolus of sc Injected Lantus Compared to NPH Insulin in Patients With Type 2 Diabetes

A Phase 4 study testing Insulin glargine in people with Diabetes Mellitus, Type 2, run by Sanofi.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To assess the duration of the metabolic effect of a sc injected single dose of either insulin glargine (LantusT) or NPH-insulin (ProtaphanT) on blood glucose control in patients with type 2 diabetes Read more about this study

Who is it for?
Ages 40 to 65 years
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Insulin glargine
Type of treatment
Injection or infusion
How many people
16 participants
Where
No sites listed yet
Study dates
Apr 2004to Jul 2005
Phase
Phase 4
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 40 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Type 2 diabetes mellitus of either gender as defined by the American Diabetes Association (3) for more than 6 months
  • BMI (as defined in Appendix A of the protocol) between 28 kg/mý and 32 kg/mý (before implementation of Amendment 1) or between 26 kg/mý and 34 kg/mý (after implementation of Amendment 1)
  • Having required treatment with insulin for at least 6 months
  • Stable glycemic control with glycohemoglobin (HbA1c) >7.5% and <9.5% (before implementation of Amendment 1) or >7.0% and <9.5% (after implementation of Amendment 1
  • Fasting serum C-peptide >0.2 pmol/mL. According to Amendment 3, five additional subjects with "low" (defined as less than or equal to 0.4 pmol/mL) and 5 subjects with "high" (defined as >0.4 pmol/mL) fasting C-peptide were to be enrolled.
  • Negative pregnancy test in female subjects of childbearing potential (only for those who were not surgically sterile or who were less than 2 years postmenopausal) at the beginning of the study
  • No findings in medical history and physical examination (cardiovascular system, chest and lungs, thyroid, abdomen, nervous system, skin and mucosae, and muscular-skeletal system) which were clinically relevant and interfering with the conduct of the study
  • Normal ECG, blood pressure, pulse rate and core body temperature unless the investigator considered an abnormality to be clinically irrelevant and not interfering with the conduct of the study

Who cannot join

  • Subjects with "brittle" diabetes or predisposition to severe hypoglycemia, e.g. 2 or more severe hypoglycemic episodes (i.e. requiring assistance of another person) within the past year, or any hospitalization or emergency room visit due to poor diabetic control within the past 6 months
  • Subjects who had been treated with insulin with a total insulin dose of >1.5 IU/kg/day
  • Pregnant and nursing women
  • Female subjects of childbearing potential (those who are not surgically sterile or who are less than 2 years postmenopausal) unwilling or unable to use reliable contraceptive measures. Reliable contraceptive measures included the following: systemic contraceptive (oral, implant, injection), diaphragm with intravaginal spermicide, cervical cap, intrauterine device, or condom with spermicide.
  • Any condition requiring the regular use of any medication if the regular use of this medication interfered with the study conduct
  • Abuse of alcoholic beverages (as defined in Appendix B of the protocol)
Show all 15Show fewer
  • Treatment with oral antidiabetic drugs within the last 4 weeks
  • Treatment in the previous 3 months with any drug known to have a well-defined potential for toxicity concerning vital organs
  • Symptoms of any major internal medical disease in the 4 weeks before the study which, according to the investigator's opinion, could interfere with the purposes of the study
  • History of hypersensitivity to any drugs that have a similar chemical structure to the study drug
  • History or presence of gastrointestinal, liver, or kidney disease or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs
  • Blood donation during the previous 3 months
  • Positive HIV- or hepatitis B/C-test
  • Progressive fatal disease
  • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

About this study

Official title: Assessment of Duration of Metabolic Effect of a Single Bolus of Subcutaneous Injected Lantus Compared to NPH-Insulin(Protaphan)in Patients With Type 2 Diabetes

To assess the duration of the metabolic effect of a sc injected single dose of either insulin glargine (LantusT) or NPH-insulin (ProtaphanT) on blood glucose control in patients with type 2 diabetes

Being tested
Insulin glargine
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 glargineDrug

    Lantus (commercial formulation, Reference):

    10 mL vials (100 IU/mL) solution Dose: 0.3 IU per kg BW injected subcutaneously in the patients usual injection site (either abdomen or thigh)

    NPH-insulin (Protaphan) (Test):

    10 mL vials (100 IU/mL) solution Dose: 0.3 IU per kg BW injected subcutaneously in the patients usual injection site (either abdomen or thigh)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To assess the duration of the metabolic effect of a sc injected single dose of either insulin glargine (LantusT) or NPH-insulin (ProtaphanT) on blood glucose control in patients with type 2 diabetes

    Measured: during the study conduct

Secondary outcomes (1)

  1. To evaluate the effect of insulin glargine (LantusT) and NPH-insulin (ProtaphanT) on suppression of endogenous glucose production, endogenous insulin secretion, and lipolysis

    Measured: during the study conduct

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Nov 2007 (estimated)
  2. Study startApr 2004
  3. Study completionJul 2005

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Participant
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00553020
Sponsor's protocol ID
HOE901_4050
Status last verified
Oct 2007
First submitted
31 Oct 2007
Last updated
2 Nov 2007
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Insulin glargine in people with Diabetes Mellitus, Type 2, run by Sanofi.

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 8 inclusion and 15 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 2 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.

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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

To assess the duration of the metabolic effect of a sc injected single dose of either insulin glargine (LantusT) or NPH-insulin (ProtaphanT) on blood glucose control in patients with type 2 diabetes (time frame: during the study conduct). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00553020.

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 2 Nov 2007.

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