Diabetes Mellitus, Type 2Phase 4TARGETNCT00347100
Insulin Glargine in Type 2 Diabetic Patients
A Phase 4 study testing Insulin Glargine, Glyburide and Glyclazide in people with Diabetes Mellitus, Type 2, run by Sanofi at 1 site in China.
Trial summary
Primary: To investigate the efficacy of insulin glargine (in terms of change in A1c from baseline to endpoint A1c < 7%) Secondary: To investigate the safety of insulin glargine (in terms of hypoglycaemia, including symptomatic, non-symptomatic and nocturnal hypoglycaemia) To investigate whether beta cell function is… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Insulin Glargine, Glyburide and Glyclazide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 387 participants
- Where
- 1 siteChina
- Study dates
- Jun 2006to May 2008
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes patients with first OAD (Sulfonylurea [SU] or Metformin) failure
- Patients who are insulin naive (unless it was used for gestational diabetes or if insulin therapy was less than 1 week)
- Serum creatinine ≤ 1.5mg/dL
- BMI: 21-41 kg/m²
- 7.5%< A1c <11%
- Fasting plasma glucose > 7.5mmol/L
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- On diet and exercise therapy and stable OAD treatment (SU or metformin > ½ maximal dose)for more than 1 month prior to enrolment
- Women not of childbearing potential (sterilization procedure done or menopausal > 2 years), or if of childbearing potential, agree to take reliable contraceptive measures during the study
- Able and willing to monitor blood glucose
- Able and willing to perform 7 point blood glucose self monitoring at baseline, 12 week and 24 week
- Understand that there is a 50% chance of being randomized to the insulin treatment arm and is willing to self inject insulin
Who cannot join
- Type 1 diabetes
- Acute complication of diabetes, such as diabetic ketoacidosis and hyperosmolar coma
- Pregnancy, breast-feeding
- People who work night shifts
- Hypersensitivity to investigational drugs or its additives, or intolerability to metformin
- Need for use of medications prohibited by the protocol during the study for treatment purpose
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- Significant diseases in cardiovascular, liver, nerve, endocrine or other systems, unable to complete the study or difficult to be used in study analysis
- Drugs or alcohol abuse
- 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: Treatment of Early Insulinization With Glargine in Type 2 Diabetes Patients Uncontrolled on Sulfonylurea or Metformin Monotherapy
Primary:
- To investigate the efficacy of insulin glargine (in terms of change in A1c from baseline to endpoint A1c < 7%)
Secondary:
- To investigate the safety of insulin glargine (in terms of hypoglycaemia, including symptomatic, non-symptomatic and nocturnal hypoglycaemia)
- To investigate whether beta cell function is preserved if this therapy is initiated before 2nd OAD (oral anti-diabetic drug) failure
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Insulin Glargine, Glyburide, Glyclazide, Glimiperide, Glipizide
- 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
Throughout study period
GlyburideDrug
Combination throughout the study period. Titrate to FPG ≤ 100 mg/dl.
GlyclazideDrug
Combination throughout the study period. Titrate to FPG ≤ 100 mg/dl.
GlimiperideDrug
Combination throughout the study period. Titrate to FPG ≤ 100 mg/dl.
GlipizideDrug
Combination throughout the study period. Titrate to FPG ≤ 100 mg/dl.
MetforminDrug
Combination throughout the study period. Titrate to FPG ≤ 100 mg/dl.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Administration of Insulin Glargine and Sulfonylurea or Metformin Receives: Drug: Insulin Glargine; Drug: Metformin |
| 2 | Active comparator | Administration of Sulfonylurea or Metformin + a second Oral Anti Diabetic (OAD) among Glyburide, Glyclazide,Glimiperide,Glipizide or Metformin Receives: Drug: Glyburide; Drug: Glyclazide; Drug: Glimiperide; Drug: Glipizide; Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
A1c values
Measured: At baseline and 24 weeks
Secondary outcomes (1)
Adverse events including hypoglycemia
Measured: From the beginning to the end of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2006 (estimated)
- Study startJun 2006
- Primary completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 387 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bruno Jolain, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00347100
- Sponsor's protocol ID
- LANTU_L_01051
- Acronym
- TARGET
- Status last verified
- Sep 2009
- First submitted
- 30 Jun 2006
- Last updated
- 15 Sep 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Early Insulinization With Glargine in Type 2 Diabetes Patients Uncontrolled on Sulfonylurea or Metformin Monotherapy
- ClinicalTrials.gov ID
- NCT00347100
- Acronym / sponsor ID
- TARGET / LANTU_L_01051
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 387 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Primary completion
- May 2008 (actual)
- First posted
- 4 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.
Primary:
- To investigate the efficacy of insulin glargine (in terms of change in A1c from baseline to endpoint A1c < 7%)
Secondary:
- To investigate the safety of insulin glargine (in terms of hypoglycaemia, including symptomatic, non-symptomatic and nocturnal hypoglycaemia)
- To investigate whether beta cell function is preserved if this therapy is initiated before 2nd OAD (oral anti-diabetic drug) failure
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Insulin Glargine, Drug: MetforminAdministration of Insulin Glargine and Sulfonylurea or Metformin |
| 2 | Active comparator | Drug: Glyburide, Drug: Glyclazide, Drug: Glimiperide, Drug: Glipizide, Drug: MetforminAdministration of Sulfonylurea or Metformin + a second Oral Anti Diabetic (OAD) among Glyburide, Glyclazide,Glimiperide,Glipizide or Metformin |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Type 2 diabetes patients with first OAD (Sulfonylurea [SU] or Metformin) failure
- Patients who are insulin naive (unless it was used for gestational diabetes or if insulin therapy was less than 1 week)
- Serum creatinine ≤ 1.5mg/dL
- BMI: 21-41 kg/m²
- 7.5%< A1c <11%
Key exclusion criteria (9 listed)
- Type 1 diabetes
- Acute complication of diabetes, such as diabetic ketoacidosis and hyperosmolar coma
- Pregnancy, breast-feeding
- People who work night shifts
- Hypersensitivity to investigational drugs or its additives, or intolerability to metformin
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 GlargineThroughout study period | Drug | 1 |
| GlyburideCombination throughout the study period. Titrate to FPG ≤ 100 mg/dl. | Drug | 2 |
| GlyclazideCombination throughout the study period. Titrate to FPG ≤ 100 mg/dl. | Drug | 2 |
| GlimiperideCombination throughout the study period. Titrate to FPG ≤ 100 mg/dl. | Drug | 2 |
| GlipizideCombination throughout the study period. Titrate to FPG ≤ 100 mg/dl. | Drug | 2 |
| MetforminCombination throughout the study period. Titrate to FPG ≤ 100 mg/dl. | Drug | 1, 2 |
Primary outcome
A1c values
Time frame: At baseline and 24 weeks
1 secondary outcome
Adverse events including hypoglycemia
Time frame: From the beginning to the end of the 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 15 Sep 2009.
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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.
Bruno Jolain 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 4 study testing Insulin Glargine, Glyburide and Glyclazide in people with Diabetes Mellitus, Type 2, run by Sanofi at 1 site in China.
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 11 inclusion and 9 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 15 Sep 2009. 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 China. 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 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?
A1c values (time frame: At baseline and 24 weeks). 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 15 Sep 2009.