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Diabetes Mellitus, Type 2Phase 4B to BNCT01212913

Comparison of Insulin Glargine/Insulin Glulisine Regimen to Insulin Aspart/Insulin Aspart Protamine 30/70 in Type 2 Diabetes Mellitus Patients (T2DM)

A Phase 4 study testing INSULIN GLARGINE, INSULIN GLULISINE and Insulin aspart in people with Diabetes Mellitus, Type 2, run by Sanofi at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Primary Objective: To demonstrate the non-inferiority of hemoglobin A1c (HbA1c) control at six months between the basal plus one and the biphasic insulin regimen. Secondary Objective: To demonstrate favorable outcome for basal plus over biphasic insulin when it comes to comparing when both hemoglobin A1c (HbA1c)… 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, INSULIN GLULISINE and Insulin aspart
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
161 participants
Where
1 siteSouth Korea
Study dates
Aug 2010to May 2012
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

  • Sub-optimally controlled Type 2 Diabetes Mellitus (T2DM) patients treated with insulin glargine for a minimum of 3 months:
  • Sub-optimal: HbA1c level >7% and fasting blood glucose <130mg/dL
  • Male or Female ≥18 years old
  • Body Mass Index (BMI) <40
  • 10% ≥HbA1c ≥7%
  • If taking Oral anti-diabetics (OADs), must be on stable dose for at least 1 months
  • Patients willing to sign data release consent form

Who cannot join

  • Diabetes other than T2DM
  • Enrolled in other clinical trials
  • Previous treatment with an insulin other than insulin glargine
  • Treatment with Glucagon-like peptide-1 (GLP-1) receptor agonists or with Di Peptidyl Peptidase 4 (DPP-IV) inhibitors
  • Pregnant or lactating women
  • Contraindicated to Lantus (insulin glargine) / Apidra (insulin glulisine) / Novomix 30 (insulin aspart)
Show all 9Show fewer
  • Treatment with systemic corticoid steroids within the last 3 months prior to study enter
  • Treatment with any investigational product within the last 3 months prior to study entry
  • 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.

South Korea1 site

  • Administrative Office

    Seoul

Other trials in South Korea

About this study

Official title: Comparison of a Basal Plus (Insulin Glargine/Insulin Glulisine) Regimen to Biphasic Insulin (InsulinAspart/Insulin Aspart Protamine 30/70) in T2DM Patients Who Require Insulin Intensification After Basal Insulin Optimization.

Primary Objective:

To demonstrate the non-inferiority of hemoglobin A1c (HbA1c) control at six months between the basal plus one and the biphasic insulin regimen.

Secondary Objective:

To demonstrate favorable outcome for basal plus over biphasic insulin when it comes to comparing when both hemoglobin A1c (HbA1c) target goal achievement and non-hypoglycemic event is taken into account.

Being tested
INSULIN GLARGINE, INSULIN GLULISINE, Insulin aspart
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

    Also called Lantus

    Pharmaceutical form: solution for injection Route of administration: subcutaneous Dose regimen: once daily

  • INSULIN GLULISINEDrug

    Also called Apidra

    Pharmaceutical form: solution for injection Route of administration: subcutaneous Dose regimen: once daily

  • Insulin aspartDrug

    Also called NovoMix 30

    Pharmaceutical form: solution for injection Route of administration: subcutaneous Dose regimen: twice daily

Study groups in NCT01212913
Study groupRoleWhat they receive
group 1: Basal plusExperimentalInsulin glargine with dosage adjustment determined according to the mean value of the last three days Fasting Blood Glucose (FBG) Insulin glulisine, at initial dosing of 4IU, then weekly adjusted according to the mean value of the last three days PostPrandial Blood Glucose (PPBG)
Receives: Drug: INSULIN GLARGINE; Drug: INSULIN GLULISINE
group 2: Biphasic insulinActive comparatorInsulin aspart/insulin aspart protamine 30/70 (novomix 30) given twice daily and titrated weekly (before breakfast and dinner) according to the lowest of three previous days' pre-meal levels (both breakfast and dinner). Target is 70 mg/dL < Pre-meal blood glucose (dinner and breakfast).
Receives: Drug: Insulin aspart

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in hemoglobin A1c level (HbA1c)

    Measured: At 6 months of treatment

Secondary outcomes (6)

  1. Rate of hypoglycemic events (total, severe, nocturnal)

    Measured: from baseline to the study endpoint (over 6 months of treatment)

  2. Proportion of patients with HbA1c < 7%

    Measured: from baseline to the study endpoint (over 6 months of treatment)

  3. Change in body weight

    Measured: from baseline to the study endpoint (over 6 months of treatment)

  4. Reactive Oxidative Stress (ROS) level changes

    Measured: from baseline to the study endpoint (over 6 months of treatment)

  5. Change in Quality of Life

    Measured: from baseline to the study endpoint (over 6 months of treatment)

  6. Continuous Glucose Monitoring System (CGMS) data

    Measured: at baseline, 3 and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2010 (estimated)
  2. Study startAug 2010
  3. Primary completionMay 2012
  4. Study completionMay 2012

Resources

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
161 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01212913
Sponsor's protocol ID
LANTU_L_04867
Other IDs
U1111-1117-2786
Acronym
B to B
Status last verified
Jul 2013
First submitted
30 Sep 2010
Last updated
8 Jul 2013
Results posted
No
Data monitoring committee
No

Publications

  • Jin SM, Kim JH, Min KW, Lee JH, Ahn KJ, Park JH, Jang HC, Park SW, Lee KW, Won KC, Kim YI, Chung CH, Park TS, Lee JH, Lee MK. Basal-prandial versus premixed insulin in patients with type 2 diabetes requiring insulin intensification after basal insulin optimization: A 24-week randomized non-inferiority trial. J Diabetes. 2016 May;8(3):405-13. doi: 10.1111/1753-0407.12312. Epub 2015 Jun 29.

    PubMed 25952532

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing INSULIN GLARGINE, INSULIN GLULISINE and Insulin aspart in people with Diabetes Mellitus, Type 2, 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 7 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 8 Jul 2013. 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?

Change in hemoglobin A1c level (HbA1c) (time frame: At 6 months 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 NCT01212913, 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 8 Jul 2013.

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