Diabetes Mellitus, Type 2Phase 4AT-LANTUSNCT00399724
A Trial Comparing Lantus Algorithms to Achieve Normal Blood Glucose Targets in Subjects With Uncontrolled Blood Sugar With Type 2 Diabetes Mellitus
A Phase 4 study testing Insulin glargine in people with Diabetes Mellitus, Type 2, run by Sanofi.
Trial summary
Primary objective: To determine the optimal treatment algorithm for the clinical use of insulin glargine based on the incidence of severe hypoglycaemia. Secondary objectives: To determine for each treatment algorithm the incidence of asymptomatic, symptomatic and nocturnal hypoglycaemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Insulin glargine
- How many people
- 7,376 participants
- Where
- No sites listed yet
- Study dates
- Mar 2002to Aug 2003
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with Type 2 Diabetes Mellitus,
- Subjects on antidiabetic treatment (oral and/or insulin therapy) for > 6 months,
- Subjects who require a basal long-acting insulin for the control of hyperglycaemia,
- HbA1c values > 7.0% and < 12 %,
- BMI < 40 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.
About this study
Official title: A Multicentre, Multinational, Randomised, Open Study to Establish the Optimal Method for Initiating and Maintaining Lantus® (Insulin Glargine) Therapy Based on a Comparison of Two Treatment Algorithms to Determine Optimal Metabolic Outcomes, Safety, and Satisfaction in Subjects With Type 2 Diabetes Mellitus.
Primary objective:
- To determine the optimal treatment algorithm for the clinical use of insulin glargine based on the incidence of severe hypoglycaemia.
Read more
Secondary objectives:
- To determine for each treatment algorithm the incidence of asymptomatic, symptomatic and nocturnal hypoglycaemia.
- To determine the difference in glycaemic control as measured by HbA1c and fasting blood glucose between the treatment algorithms.
- To determine the difference in glycaemic control as measured by HbA1c and fasting blood glucose between baseline and end of treatment.
- To obtain safety data on the use of insulin glargine in each treatment algorithm.
- To measure change in subject weight and insulin dose between baseline and end of treatment.
- To determine subject quality of life and treatment satisfaction (sub-study)
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- 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.
Insulin glargineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of severe hypoglycaemia
Secondary outcomes (15)
Incidence of any hypoglycaemia
Incidence of symptomatic hypoglycaemia
Incidence of nocturnal hypoglycaemia
Incidence of asymptomatic hypoglycaemia
Adjusted mean change in Hb1Ac (%)
Adjusted mean change in fasting blood glucose (FBG) (mg/dl)
Adjusted mean change in nocturnal blood glucose (NBG) (mg/dl)
Adjusted mean change in mean daily blood glucose (MBG) (mg/dl)
% of subjects at v12 with Hb1Ac < or = 6.5 %
% of subjects at v12 with Hb1Ac < or = 7.0 %
% of subjects at v12 with FBG < or = 100 mg/dl
Weight change (kg)
Change in insulin glargine dose v2 - v12 (IU)
Safety data
Quality of Life and treatment satisfaction before, during and at the end of treatment using the Diabetes Treatment Satisfaction Questionnaire
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2006 (estimated)
- Study startMar 2002
- Primary completionAug 2003
- Study completionAug 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- 7,376 participants
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Patrick Sinnassamy, MD, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00399724
- Sponsor's protocol ID
- HOE901_3504
- Acronym
- AT-LANTUS
- Status last verified
- Aug 2010
- First submitted
- 14 Nov 2006
- Last updated
- 31 Aug 2010
- Results posted
- No
Publications
Davies M, Lavalle-Gonzalez F, Storms F, Gomis R; AT.LANTUS Study Group. Initiation of insulin glargine therapy in type 2 diabetes subjects suboptimally controlled on oral antidiabetic agents: results from the AT.LANTUS trial. Diabetes Obes Metab. 2008 May;10(5):387-99. doi: 10.1111/j.1463-1326.2008.00873.x. Epub 2008 Mar 18.
PubMed 18355327Davies M, Sinnassamy P, Storms F, Gomis R; AT.LANTUS Study Group. Insulin glargine-based therapy improves glycemic control in patients with type 2 diabetes sub-optimally controlled on premixed insulin therapies. Diabetes Res Clin Pract. 2008 Feb;79(2):368-75. doi: 10.1016/j.diabres.2007.09.013. Epub 2007 Nov 5.
PubMed 17980928Davies M, Storms F, Shutler S, Bianchi-Biscay M, Gomis R; ATLANTUS Study Group. Improvement of glycemic control in subjects with poorly controlled type 2 diabetes: comparison of two treatment algorithms using insulin glargine. Diabetes Care. 2005 Jun;28(6):1282-8. doi: 10.2337/diacare.28.6.1282.
PubMed 15920040Khunti K, Srinivasan BT, Shutler S, Davies MJ. Effect of insulin glargine on glycaemic control and weight in obese and non-obese people with type 2 diabetes: data from the AT.LANTUS trial. Diabetes Obes Metab. 2010 Aug;12(8):683-8. doi: 10.1111/j.1463-1326.2010.01217.x.
PubMed 20590745
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Multinational, Randomised, Open Study to Establish the Optimal Method for Initiating and Maintaining Lantus® (Insulin Glargine) Therapy Based on a Comparison of Two Treatment Algorithms to Determine Optimal Metabolic Outcomes, Safety, and Satisfaction in Subjects With Type 2 Diabetes Mellitus.
- ClinicalTrials.gov ID
- NCT00399724
- Acronym / sponsor ID
- AT-LANTUS / HOE901_3504
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7,376 participants
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Mar 2002
- Primary completion
- Aug 2003 (actual)
- Study completion
- Aug 2003 (actual)
- First posted
- 15 Nov 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 objective:
- To determine the optimal treatment algorithm for the clinical use of insulin glargine based on the incidence of severe hypoglycaemia.
Secondary objectives:
- To determine for each treatment algorithm the incidence of asymptomatic, symptomatic and nocturnal hypoglycaemia.
- To determine the difference in glycaemic control as measured by HbA1c and fasting blood glucose between the treatment algorithms.
- To determine the difference in glycaemic control as measured by HbA1c and fasting blood glucose between baseline and end of treatment.
- To obtain safety data on the use of insulin glargine in each treatment algorithm.
- To measure change in subject weight and insulin dose between baseline and end of treatment.
- To determine subject quality of life and treatment satisfaction (sub-study)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects with Type 2 Diabetes Mellitus,
- Subjects on antidiabetic treatment (oral and/or insulin therapy) for > 6 months,
- Subjects who require a basal long-acting insulin for the control of hyperglycaemia,
- HbA1c values > 7.0% and < 12 %,
- BMI < 40 kg/m².
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 glargine | Drug | – |
Primary outcome
Incidence of severe hypoglycaemia
15 secondary outcomes
Incidence of any hypoglycaemia
Incidence of symptomatic hypoglycaemia
Incidence of nocturnal hypoglycaemia
Incidence of asymptomatic hypoglycaemia
Adjusted mean change in Hb1Ac (%)
Adjusted mean change in fasting blood glucose (FBG) (mg/dl)
Adjusted mean change in nocturnal blood glucose (NBG) (mg/dl)
Adjusted mean change in mean daily blood glucose (MBG) (mg/dl)
% of subjects at v12 with Hb1Ac < or = 6.5 %
% of subjects at v12 with Hb1Ac < or = 7.0 %
% of subjects at v12 with FBG < or = 100 mg/dl
Weight change (kg)
Change in insulin glargine dose v2 - v12 (IU)
Safety data
Quality of Life and treatment satisfaction before, during and at the end of treatment using the Diabetes Treatment Satisfaction Questionnaire
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 31 Aug 2010.
- Results publication: PubMed 18355327Davies M, Lavalle-Gonzalez F, Storms F, Gomis R; AT.LANTUS Study Group. Initiation of insulin glargine therapy in type 2 diabetes subjects suboptimally controlled on oral antidiabetic agents: results from the AT.LANTUS trial. Diabetes Obes Metab. 2008 May;10(5):387-99. doi: 10.1111/j.1463-1326.2008.00873.x. Epub 2008 Mar 18.
- Results publication: PubMed 17980928Davies M, Sinnassamy P, Storms F, Gomis R; AT.LANTUS Study Group. Insulin glargine-based therapy improves glycemic control in patients with type 2 diabetes sub-optimally controlled on premixed insulin therapies. Diabetes Res Clin Pract. 2008 Feb;79(2):368-75. doi: 10.1016/j.diabres.2007.09.013. Epub 2007 Nov 5.
- Results publication: PubMed 15920040Davies M, Storms F, Shutler S, Bianchi-Biscay M, Gomis R; ATLANTUS Study Group. Improvement of glycemic control in subjects with poorly controlled type 2 diabetes: comparison of two treatment algorithms using insulin glargine. Diabetes Care. 2005 Jun;28(6):1282-8. doi: 10.2337/diacare.28.6.1282.
- Derived from this study: PubMed 20590745Khunti K, Srinivasan BT, Shutler S, Davies MJ. Effect of insulin glargine on glycaemic control and weight in obese and non-obese people with type 2 diabetes: data from the AT.LANTUS trial. Diabetes Obes Metab. 2010 Aug;12(8):683-8. doi: 10.1111/j.1463-1326.2010.01217.x.
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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.
Patrick Sinnassamy, MD study director
Sanofi
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Insulin glargine in people with Diabetes Mellitus, Type 2, run by Sanofi.
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 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 31 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
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?
Incidence of severe hypoglycaemia. 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 NCT00399724, which also lists 4 linked publications.
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 31 Aug 2010.