Diabetes Mellitus, Type 2Phase 3LAPTOPNCT00783744
Insulin Glargine Combination Therapies in Type II Diabetics
A Phase 3 study testing Insulin Glargine, Glimepiride and Metformin in people with Diabetes Mellitus, Type 2, run by Sanofi at 10 sites in 10 countries.
Trial summary
To compare efficacy of combination therapy of insulin glargine plus glimepiride and metformin versus 2 injections insulin monotherapy with premixed insulin NPH 30/70 bid in terms of change of HbA1c (baseline to endpoint) to show non-inferiority of insulin glargine plus glimepiride and metformin. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Insulin Glargine, Glimepiride and Metformin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 375 participants
- Where
- 10 sitesin 10 countries
- Study dates
- Dec 2001to Aug 2003
- 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 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diabetes mellitus patients type 2, poorly controlled with oral antidiabetic drug treatment(glimepiride 3 or 4 mg od or any sulfonylurea similar to glimepiride 3 or 4 mg in combination with metformin in a dose at least similar to 850 mg once daily)
- HbA1c value ≥ 7.5 % to ≤ 10.5 %
- FBG ≥ 120 mg/dl (6.6 mmol/l)
- BMI ≤ 35 kg/m²
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Who cannot join
None listed.
Trial locations and contacts
10 sites in 10 countries.
10 sites in 10 countries
About this study
Official title: 28-week, Open, Randomized, Multinational, Multicenter Clinical Trial to Compare Efficacy and Safety of Combination Therapy of Glimepiride Plus Metformin Plus HOE901 Insulin Analogue Versus a Two-injection Conventional Therapy With Premixed Insulin NPH 30/70 Bid in Type 2 Diabetes Mellitus Patients Poorly Controlled With Oral Antidiabetic Drug Treatment.
To compare efficacy of combination therapy of insulin glargine plus glimepiride and metformin versus 2 injections insulin monotherapy with premixed insulin NPH 30/70 bid in terms of change of HbA1c (baseline to endpoint) to show non-inferiority of insulin glargine plus glimepiride and metformin.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Insulin Glargine, Glimepiride, Metformin, Insulin monotherapy with premixed insulin NPH 30/70
- 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
In the morning to target FBG ≤ 100 mg/dl
GlimepirideDrug
Glimepiride 3 or 4 mg
MetforminDrug
At least 850 mg od
Insulin monotherapy with premixed insulin NPH 30/70Drug
Given before breakfast and before dinner, target of pre-prandial BG ≤ 100 mg/dl
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Insulin Glargine + Glimepiride + Metformin Receives: Drug: Insulin Glargine; Drug: Glimepiride; Drug: Metformin |
| 2 | Active comparator | Insulin monotherapy with premixed insulin NPH 30/70 Receives: Drug: Insulin monotherapy with premixed insulin NPH 30/70 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of subjects with HbA1c ≤ 7.0 % and > 7.0 %
Measured: At endpoint
Secondary outcomes (6)
Change of fasting blood glucose
Measured: baseline to endpoint
Change of nocturnal & mean daytime blood glucose
Measured: baseline to endpoint
Change of fasting plasma glucose
Measured: baseline to endpoint and all visits
Frequency of subjects with hypoglycemic events (overall, severe, non-severe, nocturnal, asymptomatic, symptomatic)
Measured: Baseline to endpoint
Frequency of hypoglycemic events(overall, severe, non-severe, nocturnal, asymptomatic, symptomatic)
Measured: Baseline to endpoint
Frequency of subjects with FBG ≤ 100 mg/dl (5.5 mmol/l), 100 mg/dl < FBG ≤ 120 mg/dl (5.5 mmol/l < FBG ≤ 6.6 mmol/l), 120 mg/dl < FBG ≤ 150 mg/dl (6.6 mmol/l < FBG ≤ 8.3 mmol/l) and > 150 mg/dl (> 8.3 mmol/l)
Measured: At endpoint
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2008 (estimated)
- Study startDec 2001
- Primary completionAug 2003
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 375 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Christine Kliebe-Frisch, MD, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00783744
- Sponsor's protocol ID
- HOE901_4027
- Acronym
- LAPTOP
- Status last verified
- Sep 2009
- First submitted
- 31 Oct 2008
- Last updated
- 28 Sep 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 28-week, Open, Randomized, Multinational, Multicenter Clinical Trial to Compare Efficacy and Safety of Combination Therapy of Glimepiride Plus Metformin Plus HOE901 Insulin Analogue Versus a Two-injection Conventional Therapy With Premixed Insulin NPH 30/70 Bid in Type 2 Diabetes Mellitus Patients Poorly Controlled With Oral Antidiabetic Drug Treatment.
- ClinicalTrials.gov ID
- NCT00783744
- Acronym / sponsor ID
- LAPTOP / HOE901_4027
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 375 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Dec 2001
- Primary completion
- Aug 2003 (actual)
- First posted
- 3 Nov 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.
To compare efficacy of combination therapy of insulin glargine plus glimepiride and metformin versus 2 injections insulin monotherapy with premixed insulin NPH 30/70 bid in terms of change of HbA1c (baseline to endpoint) to show non-inferiority of insulin glargine plus glimepiride and metformin.
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: Glimepiride, Drug: MetforminInsulin Glargine + Glimepiride + Metformin |
| 2 | Active comparator | Drug: Insulin monotherapy with premixed insulin NPH 30/70Insulin monotherapy with premixed insulin NPH 30/70 |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diabetes mellitus patients type 2, poorly controlled with oral antidiabetic drug treatment(glimepiride 3 or 4 mg od or any sulfonylurea similar to glimepiride 3 or 4 mg in combination with metformin in a dose at least similar to 850 mg once daily)
- HbA1c value ≥ 7.5 % to ≤ 10.5 %
- FBG ≥ 120 mg/dl (6.6 mmol/l)
- BMI ≤ 35 kg/m²
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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 GlargineIn the morning to target FBG ≤ 100 mg/dl | Drug | 1 |
| GlimepirideGlimepiride 3 or 4 mg | Drug | 1 |
| MetforminAt least 850 mg od | Drug | 1 |
| Insulin monotherapy with premixed insulin NPH 30/70Given before breakfast and before dinner, target of pre-prandial BG ≤ 100 mg/dl | Drug | 2 |
Primary outcome
Frequency of subjects with HbA1c ≤ 7.0 % and > 7.0 %
Time frame: At endpoint
6 secondary outcomes
Change of fasting blood glucose
Time frame: baseline to endpoint
Change of nocturnal & mean daytime blood glucose
Time frame: baseline to endpoint
Change of fasting plasma glucose
Time frame: baseline to endpoint and all visits
Frequency of subjects with hypoglycemic events (overall, severe, non-severe, nocturnal, asymptomatic, symptomatic)
Time frame: Baseline to endpoint
Frequency of hypoglycemic events(overall, severe, non-severe, nocturnal, asymptomatic, symptomatic)
Time frame: Baseline to endpoint
Frequency of subjects with FBG ≤ 100 mg/dl (5.5 mmol/l), 100 mg/dl < FBG ≤ 120 mg/dl (5.5 mmol/l < FBG ≤ 6.6 mmol/l), 120 mg/dl < FBG ≤ 150 mg/dl (6.6 mmol/l < FBG ≤ 8.3 mmol/l) and > 150 mg/dl (> 8.3 mmol/l)
Time frame: At endpoint
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 28 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.
Christine Kliebe-Frisch, MD study director
Sanofi
10 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Insulin Glargine, Glimepiride and Metformin in people with Diabetes Mellitus, Type 2, run by Sanofi at 10 sites in 10 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 5 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 28 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 10 sites in Austria, Finland, France, Germany, Italy and 5 more countries. 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?
Frequency of subjects with HbA1c ≤ 7.0 % and > 7.0 % (time frame: At endpoint). 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 28 Sep 2009.