Insulins Glargine and gluLisine strAtegy Versus Premixed Insulin strAteGy: a cOmparative Study

Diabetes Mellitus, Type 2 Clinical Trial

— GALAPAGOS  

Official title:

A 24-week, Open, Multicenter, Comparative Study of 2 Strategies (Including Insulin Glargine Versus Premixed Insulin) for the Therapeutic Management of Patients With Type 2 Diabetes Failing Oral Agents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01121835
• Other study ID #: LANTU_C_04589
• Secondary ID: 2009-018172-33U1
• Status: Completed
• Phase: Phase 4
• First received: May 6, 2010
• Last updated: April 2, 2013
• Start date: February 2010
• Est. completion date: March 2012

Study information

• Verified date: April 2013
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: National Institute of Public Health, Health Secretariat
• Study type: Interventional

Clinical Trial Summary

Primary Objective:

To demonstrate the superiority of a strategy with insulin glargine in comparison with a strategy including the premixed insulin in term of percentage of patients reaching HbA1c (glycosylated hemoglobin) below 7% at the end of treatment and who do not experience documented symptomatic hypoglycemia (confirmed by a Plasma Glucose (PG) below 56 mg/dL (3.1 mmol/L)) over a 24-week treatment period, in Type 2 diabetes patients failing lifestyle management and oral agents.

Secondary Objectives:

To assess the effect of insulin glargine in comparison with premixed insulin on :

• Evolution of HbA1c level during the treatment period Percentage of patients who reach the target of HbA1c < 7 % and who do not experience documented symptomatic hypoglycemia confirmed by a Plasma Glucose (PG) below 70 mg/dL (3.9 mmol/L)

• Percentage of patients who reach the target of HbA1c < 6.5% and who do not experience documented symptomatic hypoglycemia confirmed by a PG below 56 mg/dL (3.1 mmol/L) >Percentage of patients who reach the target of HbA1c < 6.5% and who do not experience documented symptomatic hypoglycemia confirmed by a PG below 70 mg/dL (3.9 mmol/L) >Evolution of Fasting Plasma Glucose Evolution of 7-point plasma glucose profiles

• Evolution of weight

• Hypoglycemia occurrence

• Dose of insulins

• Evolution of liver function

• Overall safety

Recruitment information / eligibility

• Status: Completed
• Enrollment: 934
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years and older

Eligibility

Inclusion criteria:

• Type 2 diabetes diagnosed for more than 1 year

• Insulin naïve

• Treated with lifestyle interventions and oral antidiabetic drugs, at least metformin at the maximum tolerated dose (with a minimum dose of 1g/day), for at least 3 months

• HbA1c = 7.0 % and = 10.5%

• Body mass index (BMI) = 40 kg/m2

• Ability and willingness to perform plasma glucose (PG) monitoring using the sponsor-provided glucose meter and to complete the patient diary

• Willingness and ability to comply with the study protocol

• Signed informed consent obtained prior any study procedure

Exclusion criteria:

• Treatment with glucagon-like peptide-1 (GLP-1) agonists in the 3 months prior to study entry

• Previous treatment with insulin (except for treatment of gestational diabetes or brief treatment with insulin for less than 1 week)

• Diabetes other than type 2 diabetes (e.g. type 1 diabetes, diabetes secondary to pancreatic disorders, drug or chemical agent intake)

• Pregnant or lactating women (women of childbearing potential must have a negative pregnancy test at study entry and a medically approved contraception method)

• Hospitalized patient (except for routine diabetes check-up)

• Active proliferative retinopathy, as defined by a photocoagulation or vitrectomy occurrence in the 6 months prior to study entry, or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgical treatment during the study, documented by retina examination, in the 2 years prior to study entry

• History of sensitivity to the study drugs or to drugs with a similar chemical structure

• Impaired renal function: creatinine clearance < 60ml/min

• Impaired liver function (ALT, AST > 3 x upper limit of normal range)

• Severe gastro-intestinal disease

• Treatment with corticosteroids with potential systemic action within the 3 months prior to study entry

• Likelihood of requiring treatments during the study which are not permitted

• Treatment with an investigational product in the 30 days prior to study entry

• Alcohol or drug abuse within the last 5 years

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Drug:
• INSULIN GLARGINE
Pharmaceutical form: solution for injection Route of administration: sub-cutaneous injection Dose regimen: 100 Units/mL solution for injection in a pre-filled SoloStar pen (3 ml)
• INSULIN GLULISINE
Pharmaceutical form: solution for injection Route of administration: sub-cutaneous Dose regimen: 100 Units/mL solution for injection in a pre-filled SoloStar pen (3 mL)
• PREMIXED INSULIN
Pharmaceutical form: solution for injection Route of administration: sub-cutaneous Dose regimen: - 30% soluble insulin aspart and 70 % protamine-crystallised insulin aspart in pre-filled Flexpen for all the countries except Mexico 25 % insulin lispro solution and 75% insulin lispro protamine in cartridges for Humapen Luxura for Mexico only

Locations

Country	Name	City	State
Austria	Investigational Site Number 040-004	Sankt Stefan
Austria	Investigational Site Number 040-001	Vienna
Austria	Investigational Site Number 040-002	Vienna
Austria	Investigational Site Number 040-003	Vienna
Brazil	Investigational Site Number 076002	Belém
Brazil	Investigational Site Number 076005	Curitiba
Brazil	Investigational Site Number 076004	Fortaleza
Brazil	Investigational Site Number 076001	Porto Alegre
Brazil	Investigational Site Number 076003	São Paulo
China	Investigational Site Number 156004	Beijing
China	Investigational Site Number 156005	Beijing
China	Investigational Site Number 156006	Beijing
China	Investigational Site Number 156011	Chongqing
China	Investigational Site Number 156009	Dalian
China	Investigational Site Number 156008	Guangzhou
China	Investigational Site Number 156012	Haikou
China	Investigational Site Number 156007	Nanjing
China	Investigational Site Number 156001	Shanghai
China	Investigational Site Number 156002	Shanghai
China	Investigational Site Number 156003	Shanghai
China	Investigational Site Number 156010	Shenyang
Colombia	Investigational Site Number 170001	Bogota
Colombia	Investigational Site Number 170002	Bogota
Colombia	Investigational Site Number 170003	Bucaramanga
Colombia	Investigational Site Number 170005	Manizales
Colombia	Investigational Site Number 170004	Pereira
Denmark	Investigational Site Number 208-001	Hvidovre
Denmark	Investigational Site Number 208-003	København NV.
Denmark	Investigational Site Number 208-002	København S.
Greece	Investigational Site Number 300006	Alexandroupolis
Greece	Investigational Site Number 300001	Athens
Greece	Investigational Site Number 300002	Athens
Greece	Investigational Site Number 300003	Athens
Greece	Investigational Site Number 300004	Athens
Greece	Investigational Site Number 300005	Iraklion
Greece	Investigational Site Number 300011	Maroussi, Athens
Greece	Investigational Site Number 300007	Thessaloniki
Greece	Investigational Site Number 300008	Thessaloniki
Greece	Investigational Site Number 300010	Thessaloniki
India	Investigational Site Number 356003	Bangalore
India	Investigational Site Number 356007	Bangalore
India	Investigational Site Number 356008	Bangalore
India	Investigational Site Number 356006	Bhubaneshwar
India	Investigational Site Number 356001	Hyderabad
India	Investigational Site Number 356005	Hyderabad
India	Investigational Site Number 356004	Trivandrum
Italy	Investigational Site Number 380-008	Catania
Italy	Investigational Site Number 380-010	Catania
Italy	Investigational Site Number 380-006	Colleferro
Italy	Investigational Site Number 380-007	Foggia
Italy	Investigational Site Number 380-005	Forlì
Italy	Investigational Site Number 380-001	Genova
Italy	Investigational Site Number 380-011	Merano
Italy	Investigational Site Number 380-009	Napoli
Italy	Investigational Site Number 380-012	Napoli
Italy	Investigational Site Number 380-004	Parma
Korea, Republic of	Investigational Site Number 410004	Ansan-si, Kyouggi-do
Korea, Republic of	Investigational Site Number 410003	Koyang-si
Korea, Republic of	Investigational Site Number 410001	Seoul
Korea, Republic of	Investigational Site Number 410002	Seoul
Kuwait	Investigational Site Number 001	Kuwait
Mexico	Investigational Site Number 484001	Aguascalientes
Mexico	Investigational Site Number 484004	Aguascalientes
Mexico	Investigational Site Number 484002	Guadalajara
Mexico	Investigational Site Number 484003	Guadalajara
Mexico	Investigational Site Number 484005	Puebla
Romania	Investigational Site Number 642001	Iasi
Romania	Investigational Site Number 642002	Iasi
Romania	Investigational Site Number 642003	Oradea
Spain	Investigational Site Number 724001	Avila
Spain	Investigational Site Number 724002	Barcelona
Spain	Investigational Site Number 724008	Galdakao
Spain	Investigational Site Number 724007	Lugo
Spain	Investigational Site Number 724004	Madrid
Spain	Investigational Site Number 724009	Pamplona
Spain	Investigational Site Number 724005	Santa Coloma de Gramanet
Spain	Investigational Site Number 724003	Sevilla
Spain	Investigational Site Number 724006	Valencia
Taiwan	Investigational Site Number 158004	Changhua County
Taiwan	Investigational Site Number 158003	Hsintien
Taiwan	Investigational Site Number 158007	Kaohsiung Hsien,
Taiwan	Investigational Site Number 158006	New Taipei city
Taiwan	Investigational Site Number 158001	Taichung
Taiwan	Investigational Site Number 158009	Taichung City
Taiwan	Investigational Site Number 158005	Tainan
Taiwan	Investigational Site Number 158002	Taipei
Turkey	Investigational Site Number 792-013	Ankara
Turkey	Investigational Site Number 792-009	Canakkale
Turkey	Investigational Site Number 792-006	Diyarbakir
Turkey	Investigational Site Number 792-004	Istanbul
Turkey	Investigational Site Number 792-001	Izmir
Turkey	Investigational Site Number 792-016	Konya
Turkey	Investigational Site Number 792-007	Sivas
Turkey	Investigational Site Number 792-005	Trabzon
Turkey	Investigational Site Number 792-002	Van
United Arab Emirates	Investigational Site Number 784-001	Dubai

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

Austria,  Brazil,  China,  Colombia,  Denmark,  Greece,  India,  Italy,  Korea, Republic of,  Kuwait,  Mexico,  Romania,  Spain,  Taiwan,  Turkey,  United Arab Emirates, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients with Glycosylated Haemoglobin (HbA1c) <7% with no documented symptomatic hypoglycemia (confirmed by a Plasma Glucose (PG) = 56 mg/dL [3.1 mmol/L]		From baseline (visit 2, week 0) to visit 14 (week 24)	No
Secondary	7-point plasma glucose (PG) profile recorded on 3 consecutive days		From baseline (visit 2, week 0) to visit 14 (week 24)	No
Secondary	Self-monitored PG (Plasma Glucose) values over 3 consecutive days		before visit 4 (week 2)	No
Secondary	Self-monitored PG (Plasma Glucose) values over 3 consecutive days		before visit 8 (week 6)	No
Secondary	Self-monitored PG (Plasma Glucose) values over 3 consecutive days		before visit 12 (week 16)	No
Secondary	Weight and supine blood pressure		From baseline (visit 2, week 0) to visit 14 (week 24)	No
Secondary	Insulin doses of the day before each visit		from visit 3 (week 1) to visit 14 (week 24)	No
Secondary	Biochemistry and lipid profile		From baseline (visit 2, week 0) to visit 14 (week 24)	No