HyperglycemiaPhase 1NCT00348972
Lantus in Prediabetes
A Phase 1 study testing Lantus® (insulin glargine) in people with Hyperglycemia and Diabetes Mellitus, run by Sanofi at 1 site in United States.
Trial summary
To assess the safety, tolerability, and efficacy of Lantus® (insulin glargine) in prediabetes (IFG or IGT). Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperglycemia, Diabetes Mellitus
- What is being tested?
- Lantus® (insulin glargine)
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2002to not given
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Hyperglycemia (either IGT , IFG, or untreated type 2 diabetes)
- HbA1c < 7.0%
- BMI < 40kg/m2
- Able to perform moderate stationary bicycle exercise
Who cannot join
- Chronic pharmacologic treatment for hyperglycemia, past or present
- CAD
- serum creatinine > 2.0mg/dL
- BP > 180/105
- History of hypoglycemia unawareness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Safety and Tolerability of Lantus® (Insulin Glargine) in Subjects With Impaired Fasting Glucose (IFG) or Impaired Glucose Tolerance (IGT)
To assess the safety, tolerability, and efficacy of Lantus® (insulin glargine) in prediabetes (IFG or IGT).
- Conditions
- Hyperglycemia, Diabetes Mellitus
- Being tested
- Lantus® (insulin glargine)
- Keywords
- Glargine, prediabetes, impaired glucose tolerance, impaired fasting glucose
- Medical subject headings
- Hyperglycemia, Diabetes Mellitus, Prediabetic State, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lantus® (insulin glargine)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy: 8-point blood glucose measurements.
Safety / tolerability: hypoglycemia
Secondary outcomes (2)
Blood glucose in response to exercise.
Fasting supine levels of counterregulatory hormones
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2006 (estimated)
- Study startFeb 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperglycemiaStudies 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
- Parallel groups
- Masking
- Double blind
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Peter JOHNSTON, MD, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00348972
- Sponsor's protocol ID
- HOE901/1021
- Other IDs
- HOE901
- Status last verified
- Jul 2006
- First submitted
- 4 Jul 2006
- Last updated
- 6 Jul 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Safety and Tolerability of Lantus® (Insulin Glargine) in Subjects With Impaired Fasting Glucose (IFG) or Impaired Glucose Tolerance (IGT)
- ClinicalTrials.gov ID
- NCT00348972
- Acronym / sponsor ID
- HOE901/1021
- Conditions
- Hyperglycemia, Diabetes Mellitus
- Keywords
- Glargine, prediabetes, impaired glucose tolerance, impaired fasting glucose
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Feb 2002
- First posted
- 6 Jul 2006 (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.
To assess the safety, tolerability, and efficacy of Lantus® (insulin glargine) in prediabetes (IFG or IGT).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Hyperglycemia (either IGT , IFG, or untreated type 2 diabetes)
- HbA1c < 7.0%
- BMI < 40kg/m2
- Able to perform moderate stationary bicycle exercise
Key exclusion criteria (5 listed)
- Chronic pharmacologic treatment for hyperglycemia, past or present
- CAD
- serum creatinine > 2.0mg/dL
- BP > 180/105
- History of hypoglycemia unawareness
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 |
|---|---|---|
| Lantus® (insulin glargine) | Drug | – |
Primary outcome
Efficacy: 8-point blood glucose measurements.
Safety / tolerability: hypoglycemia
2 secondary outcomes
Blood glucose in response to exercise.
Fasting supine levels of counterregulatory hormones
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 6 Jul 2006.
- Related InfoLink provided by the sponsor.
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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.
Peter JOHNSTON, MD study director
Sanofi
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 Lantus® (insulin glargine) in people with Hyperglycemia and Diabetes Mellitus, run by Sanofi at 1 site in United States.
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 4 inclusion and 5 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 6 Jul 2006. 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 United States. 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?
Efficacy: 8-point blood glucose measurements.. The study lists 2 primary outcomes in all. 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 6 Jul 2006.