Type 2 Diabetes MellitusPhase 4NCT00562172
Insulin Glargine (Lantus) vs Sulfonylurea (SU) for BETA Cell Function (BETA Study)
A Phase 4 study testing Insulin glargine, Glimepiride and Metformin in people with Type 2 Diabetes Mellitus, run by Sanofi at 1 site in South Korea.
Trial summary
Primary objective: To compare long-term glycemic control and preservation of beta cell function when basal insulin or sulfonylurea is added on metformin in the early Type 2 Diabetes Mellitus patients Secondary objective: To assess the change of insulin resistance, microvascular complication incidence, patient… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Insulin glargine, Glimepiride and Metformin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2007to Oct 2010
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 Diabetes Mellitus patients on metformin monotherapy
- 7% ≤ HbA1c ≤ 12%
- 20 kg/m² ≤BMI ≤ 35 kg/m²
- Diabetes duration: at least 6 months
Who cannot join
- Type 1 Diabetes Mellitus patients
- Clinical evidence of active liver disease, or serum Alanine AminoTransferase 3 times the upper limit of the normal range
- Serum creatinine: 1.5 mg/dl for males, 1.4 mg/dl for females
- Acute and chronic metabolic acidosis, including diabetic ketoacidosis
- History of alcohol or other substance abuse
- Pregnancy or not using contraceptive in childbearing aged women
Show all 9Show fewer
- Known hypersensitivity to Lantus, SU or metformin
- Any disease or condition that in the opinion of the investigator may interfere with completion of the study
- 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: Lantus vs Sulfonylurea as add-on Therapy in Type 2 Diabetic Patients Failing Metformin Monotherapy: Comparison of Effects on Beta Cell Function and Metabolic Profile.
Primary objective:
To compare long-term glycemic control and preservation of beta cell function when basal insulin or sulfonylurea is added on metformin in the early Type 2 Diabetes Mellitus patients
Secondary objective:
To assess the change of insulin resistance, microvascular complication incidence, patient satisfaction with treatment
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Insulin glargine, Glimepiride, Metformin
- 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
Once daily in the morning
GlimepirideDrug
Once daily in the morning
MetforminDrug
At least 1000 mg/day
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Insulin glargine; Drug: Metformin |
| 2 | Active comparator | Not described Receives: Drug: Glimepiride; Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
ß-cell Function parameter
Measured: From the signature of the Informed Consent Form (ICF) up to the end of study
Glucose Homeostasis and glycemic control status
Measured: From the signature of the Informed Consent Form (ICF) up to the end of study
Secondary outcomes (1)
Insulin resistance parameter, Hypoglycemic episode, symptomatic, Weight change, Lipid profile, Inflammatory markers (CRP, Adiponectin, etcs), Patient satisfaction with diabetes treatment, Urine analysis, Creatinine
Measured: 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 posted21 Nov 2007 (estimated)
- Study startSep 2007
- Primary completionOct 2010
- Study completionOct 2010
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
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ji Young Ahn, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00562172
- Sponsor's protocol ID
- LANTU_L_02193
- Status last verified
- Jul 2012
- First submitted
- 15 Nov 2007
- Last updated
- 17 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Moon JS, Ha KS, Yoon JS, Lee HW, Lee HC, Won KC; BETA study group. The effect of glargine versus glimepiride on pancreatic beta-cell function in patients with type 2 diabetes uncontrolled on metformin monotherapy: open-label, randomized, controlled study. Acta Diabetol. 2014 Apr;51(2):277-85. doi: 10.1007/s00592-013-0553-z. Epub 2014 Jan 21.
PubMed 24445656
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lantus vs Sulfonylurea as add-on Therapy in Type 2 Diabetic Patients Failing Metformin Monotherapy: Comparison of Effects on Beta Cell Function and Metabolic Profile.
- ClinicalTrials.gov ID
- NCT00562172
- Acronym / sponsor ID
- LANTU_L_02193
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 21 Nov 2007 (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 compare long-term glycemic control and preservation of beta cell function when basal insulin or sulfonylurea is added on metformin in the early Type 2 Diabetes Mellitus patients
Secondary objective:
To assess the change of insulin resistance, microvascular complication incidence, patient satisfaction with treatment
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: Metformin |
| 2 | Active comparator | Drug: Glimepiride, Drug: Metformin |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Type 2 Diabetes Mellitus patients on metformin monotherapy
- 7% ≤ HbA1c ≤ 12%
- 20 kg/m² ≤BMI ≤ 35 kg/m²
- Diabetes duration: at least 6 months
Key exclusion criteria (9 listed)
- Type 1 Diabetes Mellitus patients
- Clinical evidence of active liver disease, or serum Alanine AminoTransferase 3 times the upper limit of the normal range
- Serum creatinine: 1.5 mg/dl for males, 1.4 mg/dl for females
- Acute and chronic metabolic acidosis, including diabetic ketoacidosis
- 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 |
|---|---|---|
| Insulin glargineOnce daily in the morning | Drug | 1 |
| GlimepirideOnce daily in the morning | Drug | 2 |
| MetforminAt least 1000 mg/day | Drug | 1, 2 |
Primary outcome
ß-cell Function parameter
Time frame: From the signature of the Informed Consent Form (ICF) up to the end of study
Glucose Homeostasis and glycemic control status
Time frame: From the signature of the Informed Consent Form (ICF) up to the end of study
1 secondary outcome
Insulin resistance parameter, Hypoglycemic episode, symptomatic, Weight change, Lipid profile, Inflammatory markers (CRP, Adiponectin, etcs), Patient satisfaction with diabetes treatment, Urine analysis, Creatinine
Time frame: 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 17 Jul 2012.
- Derived from this study: PubMed 24445656Moon JS, Ha KS, Yoon JS, Lee HW, Lee HC, Won KC; BETA study group. The effect of glargine versus glimepiride on pancreatic beta-cell function in patients with type 2 diabetes uncontrolled on metformin monotherapy: open-label, randomized, controlled study. Acta Diabetol. 2014 Apr;51(2):277-85. doi: 10.1007/s00592-013-0553-z. Epub 2014 Jan 21.
Related trials for Type 2 Diabetes Mellitus
Active, not recruitingPhase 2
A Study on the Safety and Clinical Efficacy of Guominkang in the Treatment of Diabetic Kidney Disease
Diabetic Kidney Disease (DKD), Type 2 Diabetes
Recruiting
Culturally Tailored Program for Food-Insecure Adults: SPICE-D
Type 2 Diabetes Mellitus (T2D)
Not yet recruiting
Evaluation of the Effectiveness of Implementing a Screening Strategy for the Diagnosis of Prediabetes and Type 2 Diabetes Mellitus in Primary Health Care in a Brazilian Municipality
Diabetes Mellitus (Type 2), Prediabetes
Active, not recruitingPhase 1/2
A First-In-Human Study of ARO-INHBE in Adults With Obesity With and Without Type 2 Diabetes Mellitus
Obesity
Not yet recruiting
Role of Endothelial Dysfunction on Exercise Pressor Reflex in Type 2 Diabetes
Type 2 Diabetes (T2DM), Endothelial Dysfunction
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 Insulin glargine, Glimepiride and Metformin 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 4 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 17 Jul 2012. 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?
ß-cell Function parameter (time frame: From the signature of the Informed Consent Form (ICF) up to the end of study). 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?
On the ClinicalTrials.gov record for NCT00562172, 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 17 Jul 2012.