Diabetes Mellitus, Type 2Phase 3NCT00653341
Effect of Insulin Glargine in Insulin Naïve Subjects With Type 2 Diabetes on Oral Hypoglycemic Agent(s)
A Phase 3 study testing insulin glargine and NPH human insulin in people with Diabetes Mellitus, Type 2, run by Sanofi at 2 sites in 2 countries.
Trial summary
The primary objective of this study is to compare the percentage of subjects who reach the target HbA1c level (< or = 7.0% at endpoint) and do not experience symptomatic nocturnal hypoglycemia during treatment with insulin glargine or NPH human insulin. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- insulin glargine and NPH human insulin
- How many people
- 764 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jan 2000to Oct 2001
- Phase
- Phase 3
- 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Insulin naïve subjects with type 2 diabetes treated with oral hypoglycemic agents
- Body mass index between 26 and 40 kg/m2
- HbA1c between 7.5% and 10.0%
- Fasting plasma glucose >7.8 mmol/L and fasting C-peptide > or =0.25 nmol/L
Who cannot join
None listed.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Sanofi-aventis administrative office
Bridgewater, New Jersey, 08807
About this study
Official title: Target Glycemic Control and the Incidence of Symptomatic Nocturnal Hypoglycemia in Insulin Naïve Subjects With Type 2 Diabetes on Oral Hypoglycemic Agent(s) and Treated With Insulin Glargine or NPH Human Insulin.
The primary objective of this study is to compare the percentage of subjects who reach the target HbA1c level (< or = 7.0% at endpoint) and do not experience symptomatic nocturnal hypoglycemia during treatment with insulin glargine or NPH human insulin.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- insulin glargine, NPH human insulin
- Keywords
- insulin naive
- 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
NPH human insulinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects reaching target HbA1c = or < 7% at endpoint and not experiencing symptomatic nocturnal hypoglycemia
Secondary outcomes (1)
Safety data (Adverse events, vital signs, laboratory values, etc.)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2008 (estimated)
- Study startJan 2000
- Primary completionOct 2001
- Study completionOct 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 764 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Public Registry ICD, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00653341
- Sponsor's protocol ID
- HOE901/4002
- Status last verified
- Apr 2009
- First submitted
- 1 Apr 2008
- Last updated
- 20 Apr 2009
- Results posted
- No
Publications
Riddle MC, Rosenstock J, Gerich J; Insulin Glargine 4002 Study Investigators. The treat-to-target trial: randomized addition of glargine or human NPH insulin to oral therapy of type 2 diabetic patients. Diabetes Care. 2003 Nov;26(11):3080-6. doi: 10.2337/diacare.26.11.3080.
PubMed 14578243Semlitsch T, Engler J, Siebenhofer A, Jeitler K, Berghold A, Horvath K. (Ultra-)long-acting insulin analogues versus NPH insulin (human isophane insulin) for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Nov 9;11(11):CD005613. doi: 10.1002/14651858.CD005613.pub4.
PubMed 33166419
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Target Glycemic Control and the Incidence of Symptomatic Nocturnal Hypoglycemia in Insulin Naïve Subjects With Type 2 Diabetes on Oral Hypoglycemic Agent(s) and Treated With Insulin Glargine or NPH Human Insulin.
- ClinicalTrials.gov ID
- NCT00653341
- Acronym / sponsor ID
- HOE901/4002
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- insulin naive
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 764 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jan 2000
- Primary completion
- Oct 2001 (actual)
- Study completion
- Oct 2001 (actual)
- First posted
- 4 Apr 2008 (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.
The primary objective of this study is to compare the percentage of subjects who reach the target HbA1c level (< or = 7.0% at endpoint) and do not experience symptomatic nocturnal hypoglycemia during treatment with insulin glargine or NPH human insulin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Insulin naïve subjects with type 2 diabetes treated with oral hypoglycemic agents
- Body mass index between 26 and 40 kg/m2
- HbA1c between 7.5% and 10.0%
- Fasting plasma glucose >7.8 mmol/L and fasting C-peptide > or =0.25 nmol/L
Key exclusion criteria (0 listed)
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 glargine | Drug | – |
| NPH human insulin | Drug | – |
Primary outcome
Percentage of subjects reaching target HbA1c = or < 7% at endpoint and not experiencing symptomatic nocturnal hypoglycemia
1 secondary outcome
Safety data (Adverse events, vital signs, laboratory values, etc.)
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 20 Apr 2009.
- Results publication: PubMed 14578243Riddle MC, Rosenstock J, Gerich J; Insulin Glargine 4002 Study Investigators. The treat-to-target trial: randomized addition of glargine or human NPH insulin to oral therapy of type 2 diabetic patients. Diabetes Care. 2003 Nov;26(11):3080-6. doi: 10.2337/diacare.26.11.3080.
- Derived from this study: PubMed 33166419Semlitsch T, Engler J, Siebenhofer A, Jeitler K, Berghold A, Horvath K. (Ultra-)long-acting insulin analogues versus NPH insulin (human isophane insulin) for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Nov 9;11(11):CD005613. doi: 10.1002/14651858.CD005613.pub4.
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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.
Public Registry ICD study director
Sanofi
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing insulin glargine and NPH human insulin in people with Diabetes Mellitus, Type 2, run by Sanofi at 2 sites in 2 countries.
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 0 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 20 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Canada. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Percentage of subjects reaching target HbA1c = or < 7% at endpoint and not experiencing symptomatic nocturnal hypoglycemia. 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 NCT00653341, which also lists 2 linked publications.
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 20 Apr 2009; AzTrials last refreshed its copy on 7 Nov 2026.