Comparison of Insulin Glargine/Insulin Glulisine Regimen to Insulin Aspart/Insulin Aspart Protamine 30/70 in Type 2 Diabetes Mellitus Patients (T2DM)
NCT ID: NCT01212913
Last Updated: 2013-07-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
161 participants
INTERVENTIONAL
2010-08-31
2012-05-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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group 1: Basal plus
Insulin 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)
INSULIN GLARGINE
Pharmaceutical form: solution for injection Route of administration: subcutaneous Dose regimen: once daily
INSULIN GLULISINE
Pharmaceutical form: solution for injection Route of administration: subcutaneous Dose regimen: once daily
group 2: Biphasic insulin
Insulin 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).
Insulin aspart
Pharmaceutical form: solution for injection Route of administration: subcutaneous Dose regimen: twice daily
Interventions
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INSULIN GLARGINE
Pharmaceutical form: solution for injection Route of administration: subcutaneous Dose regimen: once daily
INSULIN GLULISINE
Pharmaceutical form: solution for injection Route of administration: subcutaneous Dose regimen: once daily
Insulin aspart
Pharmaceutical form: solution for injection Route of administration: subcutaneous Dose regimen: twice daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Sub-optimal: HbA1c level \>7% and fasting blood glucose \<130mg/dL
2. Male or Female ≥18 years old
3. Body Mass Index (BMI) \<40
4. 10% ≥HbA1c ≥7%
5. If taking Oral anti-diabetics (OADs), must be on stable dose for at least 1 months
6. Patients willing to sign data release consent form
Exclusion Criteria
2. Enrolled in other clinical trials
3. Previous treatment with an insulin other than insulin glargine
4. Treatment with Glucagon-like peptide-1 (GLP-1) receptor agonists or with Di Peptidyl Peptidase 4 (DPP-IV) inhibitors
5. Pregnant or lactating women
6. Contraindicated to Lantus (insulin glargine) / Apidra (insulin glulisine) / Novomix 30 (insulin aspart)
7. Treatment with systemic corticoid steroids within the last 3 months prior to study enter
8. 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.
18 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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Administrative Office
Seoul, , South Korea
Countries
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References
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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.
Other Identifiers
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U1111-1117-2786
Identifier Type: OTHER
Identifier Source: secondary_id
LANTU_L_04867
Identifier Type: -
Identifier Source: org_study_id
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