Type 2 Diabetes MellitusPhase 4NCT00708578
Optimal Oral Hypoglycaemic Agents (OHA) for Combination With Insulin Glargine (Sulfonylurea vs. Metformin)
A Phase 4 study testing Glimepiride, Metformin and Insulin Glargine in people with Type 2 Diabetes Mellitus, run by Sanofi at 1 site in South Korea.
Trial summary
Primary objective: To find out an optimal regimen of OHA (oral hypoglycaemic agents) in combination with insulin glargine (metformin, glimepiride or metformin+glimepiride) by measuring HbA1c level Secondary objective: To compare the incidence of hypoglycemia in each treatment group Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Glimepiride, Metformin and Insulin Glargine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2008to Dec 2009
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes for at least 6 months
- Treated with maximal, tolerable dose of metformin (≥ 1000mg/day) and sulfonylurea (glimepiride≥ 4 mg/day or equivalent dose of other SU) for at least 3 months prior to the screening visit
- 7.0 < HbA1c < 11 %
- Fasting serum C-peptide > 0.33 nmol/L
- BMI < 30 kg/m²
- Patients who is willing to monitor BG using SMBG
Who cannot join
- Type 1 Diabetes
- Clinical evidence of active liver disease, or serum ALT 3 times the upper limit of the normal range
- Serum creatinine: ≥ 1.5 mg/dl for males, ≥ 1.4 mg/dl for females
- Active proliferative diabetic retinopathy, as defined by the application of photocoagulation or surgery, in the 6 months before study entry or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgery during the study (an optic fundus examination should have been performed in the 2 years prior to study entry)
- History of alcohol or other substance abuse
- Pregnancy or not using contraceptive in childbearing aged women
Show all 10Show fewer
- Breast feeding women
- History of hypersensitivity to the study drugs or to drugs with a similar chemical structure
- Treatment with any medication including corticosteroid or herbal medicines that can affect blood glucose level within 3 months prior to study entry except metformin and sulfonylurea.
- 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: Insulin Glargine Combined With Sulfonylurea Versus Metformin in Patients With Type 2 Diabetes: A Randomized, Controlled Trial.
Primary objective:
To find out an optimal regimen of OHA (oral hypoglycaemic agents) in combination with insulin glargine (metformin, glimepiride or metformin+glimepiride) by measuring HbA1c level
Secondary objective:
To compare the incidence of hypoglycemia in each treatment group
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Glimepiride, Metformin, 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.
GlimepirideDrug
Once a day before breakfast
MetforminDrug
After breakfast and supper
Insulin GlargineDrug
Injection in the morning
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Administration of 4 mg of Glimepiride with Insulin Glargine Receives: Drug: Glimepiride; Drug: Insulin Glargine |
| 2 | Active comparator | Administration of 1500 mg of Metformin with Insulin Glargine Receives: Drug: Metformin; Drug: Insulin Glargine |
| 3 | Experimental | Administration of a combination of 4mg Glimepiride plus 1000mg Metformin with Insulin Glargine Receives: Drug: Glimepiride; Drug: Metformin; Drug: Insulin Glargine |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c values
Measured: At baseline to end of treatment
Secondary outcomes (3)
Hypoglycemia events
Measured: From inclusion to end of study
Percentage of patients with HbA1c < 7%
Measured: At the end of the study
Fasting Blood Glucose level
Measured: At 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 posted2 Jul 2008 (estimated)
- Study startMay 2008
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies 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
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Ji Young Ahn, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00708578
- Sponsor's protocol ID
- LANTU_L_02670
- Status last verified
- Jan 2011
- First submitted
- 27 Jun 2008
- Last updated
- 25 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Park CY, Kang JG, Chon S, Noh J, Oh SJ, Lee CB, Park SW. Comparison between the therapeutic effect of metformin, glimepiride and their combination as an add-on treatment to insulin glargine in uncontrolled patients with type 2 diabetes. PLoS One. 2014 Mar 10;9(3):e87799. doi: 10.1371/journal.pone.0087799. eCollection 2014.
PubMed 24614911
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insulin Glargine Combined With Sulfonylurea Versus Metformin in Patients With Type 2 Diabetes: A Randomized, Controlled Trial.
- ClinicalTrials.gov ID
- NCT00708578
- Acronym / sponsor ID
- LANTU_L_02670
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 2 Jul 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.
Primary objective:
To find out an optimal regimen of OHA (oral hypoglycaemic agents) in combination with insulin glargine (metformin, glimepiride or metformin+glimepiride) by measuring HbA1c level
Secondary objective:
To compare the incidence of hypoglycemia in each treatment group
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Glimepiride, Drug: Insulin GlargineAdministration of 4 mg of Glimepiride with Insulin Glargine |
| 2 | Active comparator | Drug: Metformin, Drug: Insulin GlargineAdministration of 1500 mg of Metformin with Insulin Glargine |
| 3 | Experimental | Drug: Glimepiride, Drug: Metformin, Drug: Insulin GlargineAdministration of a combination of 4mg Glimepiride plus 1000mg Metformin with Insulin Glargine |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Type 2 diabetes for at least 6 months
- Treated with maximal, tolerable dose of metformin (≥ 1000mg/day) and sulfonylurea (glimepiride≥ 4 mg/day or equivalent dose of other SU) for at least 3 months prior to the screening visit
- 7.0 < HbA1c < 11 %
- Fasting serum C-peptide > 0.33 nmol/L
- BMI < 30 kg/m²
Key exclusion criteria (10 listed)
- Type 1 Diabetes
- Clinical evidence of active liver disease, or serum ALT 3 times the upper limit of the normal range
- Serum creatinine: ≥ 1.5 mg/dl for males, ≥ 1.4 mg/dl for females
- Active proliferative diabetic retinopathy, as defined by the application of photocoagulation or surgery, in the 6 months before study entry or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgery during the study (an optic fundus examination should have been performed in the 2 years prior to study entry)
- History of alcohol or other substance abuse
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 |
|---|---|---|
| GlimepirideOnce a day before breakfast | Drug | 1, 3 |
| MetforminAfter breakfast and supper | Drug | 2, 3 |
| Insulin GlargineInjection in the morning | Drug | 1, 2, 3 |
Primary outcome
HbA1c values
Time frame: At baseline to end of treatment
3 secondary outcomes
Hypoglycemia events
Time frame: From inclusion to end of study
Percentage of patients with HbA1c < 7%
Time frame: At the end of the study
Fasting Blood Glucose level
Time frame: At 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 25 Jan 2011.
- Derived from this study: PubMed 24614911Park CY, Kang JG, Chon S, Noh J, Oh SJ, Lee CB, Park SW. Comparison between the therapeutic effect of metformin, glimepiride and their combination as an add-on treatment to insulin glargine in uncontrolled patients with type 2 diabetes. PLoS One. 2014 Mar 10;9(3):e87799. doi: 10.1371/journal.pone.0087799. eCollection 2014.
Related trials for Type 2 Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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.
Ji Young Ahn 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 Glimepiride, Metformin and Insulin Glargine in people with Type 2 Diabetes Mellitus, run by Sanofi at 1 site in South Korea.
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 6 inclusion and 10 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 25 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 South Korea. 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?
HbA1c values (time frame: At baseline to end of treatment). 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 NCT00708578, which also lists 1 linked publication.
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 25 Jan 2011.