Diabetes Mellitus, Type 2Phase 4NCT00283049
Insulin Glargine Injection Treatment in Place of Thiazolidinedione (TZD), Sulfonylurea, or Metformin in Triple Agent Therapy for Type 2 Diabetes Mellitus (T2DM) Adult Subjects With Unsatisfactory Control
A Phase 4 study testing Insulin Glargine and Insulin Glulisine in people with Diabetes Mellitus, Type 2, run by Sanofi at 1 site in United States.
Trial summary
The purpose of this study is to compare the change in hemoglobin A1c (HbA1c) from baseline to Week 12 between the 3 treatment arms. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Insulin Glargine and Insulin Glulisine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 390 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2006to Nov 2008
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects meeting all of the following criteria will be considered for enrollment into the study:
- 18 to 79 years of age, inclusive
- Diagnosis of type 2 diabetes mellitus
- Continuous treatment with therapeutic dosages of a thiazolidinedione (rosiglitazone or pioglitazone), metformin, and a sulfonylurea daily prior to entering the study
- Screening HbA1c ≥ 7.0%
- Fasting C-peptide concentration ≥ 0.27 ng/ml
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- Negative glutamic acid decarboxylase (GAD) antibodies
- Demonstrated ability and willingness to perform self-monitoring blood glucose (SMBG) using a plasma-referenced glucose meter and to maintain an electronic diary
- Demonstrated ability and willingness to use an electronic diary to record SMBG results, insulin doses, and hypoglycemic events.
- Signed, informed consent and Health Insurance Portability and Accountability Act (HIPAA) documentation
Who cannot join
- Stroke, myocardial infarction, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, or angina pectoris, within the last 12 months
- Cardiac status New York Heart Association (NYHA) III-IV
- Impaired renal function as shown by, but not limited to, serum creatinine ≥ 1.5 mg/dL for males, or ≥ 1.4 mg/dL for females
- Chronic use of insulin: (more than 3 weeks of continuous use) in the past 12 months
- Acute infection
- Clinically significant peripheral edema
Show all 19Show fewer
- Acute or chronic history of metabolic acidosis, including diabetic ketoacidosis
- Clinical evidence of active liver disease, or serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) 2.5 times the upper limit of the normal range
- History of hypoglycemia unawareness
- Pregnancy or lactation
- Known hypersensitivity to insulin glargine or any of the components of Lantus®
- Known hypersensitivity to insulin glulisine or any of the components of Apidra®
- Any malignancy within the last 5 years, with the exception of adequately treated basal or squamous cell carcinoma of the skin or adequately treated cervical carcinoma in situ
- Current addiction or current alcohol abuse, or history of substance or alcohol abuse within the last 2 years
- Diagnosis of dementia
- Subject is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol
- Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study. Subject unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study
- subject is currently taking or was treated with the following medications 3 months prior to screening: Byetta(exenatide), Starlix(nateglinide),Prandin (repaglinide), Januvia(sitagliptin), Janumet(metformin + sitagliptin)
- Any disease or condition that in the opinion of the investigator and/or sponsor may interfere with the completion of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy of Insulin Glargine Injection [rDNA Origin] Treatment in Place of the TZD or the Sulfonylurea or Metformin in Triple Agent Therapy for T2DM Adult Subjects With Unsatisfactory Control
The purpose of this study is to compare the change in hemoglobin A1c (HbA1c) from baseline to Week 12 between the 3 treatment arms.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Insulin Glargine, Insulin Glulisine
- 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
Insulin glargine administered subcutaneously once daily.
Insulin GlulisineDrug
Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
| Study group | Role | What they receive |
|---|---|---|
| Insulins + Sulfonylurea (SU) + Thiazolidinedione (TZD) | Experimental | Arm 1: Insulin glargine administered subcutaneously once daily plus a sulfonylurea and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%) Receives: Drug: Insulin Glargine; Drug: Insulin Glulisine |
| Insulins + Metformin (MET) + Thiazolidinedione (TZD) | Experimental | Arm 2: Insulin glargine administered subcutaneously once daily plus metformin and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%) Receives: Drug: Insulin Glargine; Drug: Insulin Glulisine |
| Insulins + Metformin (MET) + Sulfonylurea (SU) | Experimental | Arm 3: Insulin glargine administered subcutaneously once daily plus metformin and a sulfonylurea. Insulin glulisine will be added arms after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%) Receives: Drug: Insulin Glargine; Drug: Insulin Glulisine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hemoglobin A1c (HbA1c) From Baseline to Week 12
Measured: 12 weeks from Baseline
Secondary outcomes (6)
Change From Baseline to Individual Time Points in HbA1c, Insulin Doses, and Total Insulin Dosage
Measured: 60 weeks from Baseline
Percentage of Subjects Achieving an HbA1C Less Than (<) 7.0% and Less Than (<) 6.5%
Measured: 60 weeks from Baseline
Change From Baseline to Study Time Points in 7-point Blood Glucose (BG) Profile (Before Meals, 2 Hours After Meals, at Bedtime)
Measured: 60 weeks from Baseline
Change From Baseline to End of Study and to Individual Time Points in Components of Lipid Profile (Total Cholesterol, High-density Lipoprotein Cholesterol [HDL], Low-density Lipoprotein Cholesterol [LDL], Triglycerides, LDL Subfractions)
Measured: 60 weeks from Baseline
Occurrences of Hypoglycemia, Symptomatic Hypoglycemia, Severe Hypoglycemia, and Serious Hypoglycemia
- Symptomatic hypoglycemia (BG<70 mg/dL, BG<50 mg/dL): including 1 or more symptoms: headache, dizziness, general feeling of weakness, drowsiness, confusion, pallor, irritability, trembling, sweating, rapid heartbeat \& a cold, clammy feeling.
- Mild-to-moderate hypoglycemia: SMBG ≥ 36 mg/dL but <70 mg/dL
- Severe hypoglycemia: assistance of another party is required \& either:
- SMBG of <36 mg/dL, or
- with prompt response to treatment with oral carbohydrates, IV glucose or glucagon.
- Serious hypoglycemia:
- Hypoglycemia with coma/loss of consciousness Or Hypoglycemia seizure/convulsion.
Measured: 60 weeks from Baseline
Rate of Hypoglycemia, Symptomatic Hypoglycemia, Severe Hypoglycemia and Serious Hypoglycemia
- Symptomatic hypoglycemia (BG<70 mg/dL, BG<50 mg/dL): including 1 or more symptoms: headache, dizziness, general feeling of weakness, drowsiness, confusion, pallor, irritability, trembling, sweating, rapid heartbeat \& a cold, clammy feeling.
- Mild-to-moderate hypoglycemia: SMBG ≥ 36 mg/dL but <70 mg/dL
- Severe hypoglycemia: assistance of another party is required \& either:
- SMBG of <36 mg/dL, or
- with prompt response to treatment with oral carbohydrates, IV glucose or glucagon.
- Serious hypoglycemia:
- Hypoglycemia with coma/loss of consciousness Or Hypoglycemia seizure/convulsion.
Measured: 60 Weeks from Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2006 (estimated)
- Study startFeb 2006
- Primary completionNov 2008
- Study completionNov 2008
Why it stopped: Due to technical issues relating to the Electronic diary data.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 390 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Lisa Jean-Louis, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00283049
- Sponsor's protocol ID
- HOE901_4052
- Status last verified
- Jan 2011
- First submitted
- 26 Jan 2006
- Last updated
- 13 Jan 2011
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Insulin Glargine Injection [rDNA Origin] Treatment in Place of the TZD or the Sulfonylurea or Metformin in Triple Agent Therapy for T2DM Adult Subjects With Unsatisfactory Control
- ClinicalTrials.gov ID
- NCT00283049
- Acronym / sponsor ID
- HOE901_4052
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to technical issues relating to the Electronic diary data.
- Enrolment
- 390 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Feb 2006
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 27 Jan 2006 (estimated)
- Results
- Posted 19 Feb 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the change in hemoglobin A1c (HbA1c) from baseline to Week 12 between the 3 treatment arms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Insulins + Sulfonylurea (SU) + Thiazolidinedione (TZD) | Experimental | Drug: Insulin Glargine, Drug: Insulin GlulisineArm 1: Insulin glargine administered subcutaneously once daily plus a sulfonylurea and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%) |
| Insulins + Metformin (MET) + Thiazolidinedione (TZD) | Experimental | Drug: Insulin Glargine, Drug: Insulin GlulisineArm 2: Insulin glargine administered subcutaneously once daily plus metformin and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%) |
| Insulins + Metformin (MET) + Sulfonylurea (SU) | Experimental | Drug: Insulin Glargine, Drug: Insulin GlulisineArm 3: Insulin glargine administered subcutaneously once daily plus metformin and a sulfonylurea. Insulin glulisine will be added arms after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%) |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subjects meeting all of the following criteria will be considered for enrollment into the study:
- 18 to 79 years of age, inclusive
- Diagnosis of type 2 diabetes mellitus
- Continuous treatment with therapeutic dosages of a thiazolidinedione (rosiglitazone or pioglitazone), metformin, and a sulfonylurea daily prior to entering the study
- Screening HbA1c ≥ 7.0%
Key exclusion criteria (19 listed)
- Stroke, myocardial infarction, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, or angina pectoris, within the last 12 months
- Cardiac status New York Heart Association (NYHA) III-IV
- Impaired renal function as shown by, but not limited to, serum creatinine ≥ 1.5 mg/dL for males, or ≥ 1.4 mg/dL for females
- Chronic use of insulin: (more than 3 weeks of continuous use) in the past 12 months
- Acute infection
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 GlargineInsulin glargine administered subcutaneously once daily. | Drug | Insulins + Metformin (MET) + Sulfonylurea (SU), Insulins + Metformin (MET) + Thiazolidinedione (TZD), Insulins + Sulfonylurea (SU) + Thiazolidinedione (TZD) |
| Insulin GlulisineInsulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%) | Drug | Insulins + Metformin (MET) + Sulfonylurea (SU), Insulins + Metformin (MET) + Thiazolidinedione (TZD), Insulins + Sulfonylurea (SU) + Thiazolidinedione (TZD) |
Primary outcome
Change in Hemoglobin A1c (HbA1c) From Baseline to Week 12
Time frame: 12 weeks from Baseline
6 secondary outcomes
Change From Baseline to Individual Time Points in HbA1c, Insulin Doses, and Total Insulin Dosage
Time frame: 60 weeks from Baseline
Percentage of Subjects Achieving an HbA1C Less Than (<) 7.0% and Less Than (<) 6.5%
Time frame: 60 weeks from Baseline
Change From Baseline to Study Time Points in 7-point Blood Glucose (BG) Profile (Before Meals, 2 Hours After Meals, at Bedtime)
Time frame: 60 weeks from Baseline
Change From Baseline to End of Study and to Individual Time Points in Components of Lipid Profile (Total Cholesterol, High-density Lipoprotein Cholesterol [HDL], Low-density Lipoprotein Cholesterol [LDL], Triglycerides, LDL Subfractions)
Time frame: 60 weeks from Baseline
Occurrences of Hypoglycemia, Symptomatic Hypoglycemia, Severe Hypoglycemia, and Serious Hypoglycemia
Time frame: 60 weeks from Baseline
Rate of Hypoglycemia, Symptomatic Hypoglycemia, Severe Hypoglycemia and Serious Hypoglycemia
Time frame: 60 Weeks from Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Lisa Jean-Louis 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 and Insulin Glulisine in people with Diabetes Mellitus, Type 2, 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 10 inclusion and 19 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: stopped early, as of the sponsor's last update on 13 Jan 2011. 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 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?
Yes. Results are posted in the registry (first posted 19 Feb 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Hemoglobin A1c (HbA1c) From Baseline to Week 12 (time frame: 12 weeks from Baseline). 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 13 Jan 2011.