AzTrials
AzTrials

Diabetes Mellitus, Type 2Phase 4GALAPAGOSNCT01121835

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

A Phase 4 study testing INSULIN GLARGINE, INSULIN GLULISINE and PREMIXED INSULIN in people with Diabetes Mellitus, Type 2, run by Sanofi at 96 sites in 16 countries.

Completed

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

Official record

Search all trials

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… Read more about this study

Who is it for?
Ages 35 years and older
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
INSULIN GLARGINE, INSULIN GLULISINE and PREMIXED INSULIN
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
934 participants
Where
96 sitesin 16 countries
Study dates
Feb 2010to Mar 2012
Phase
Phase 4

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 15Show fewer
  • 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.

Trial locations and contacts

96 sites in 16 countries.

96 sites in 16 countries

China12 sites

  • Investigational Site Number 156004

    Beijing

  • Investigational Site Number 156005

    Beijing

  • Investigational Site Number 156006

    Beijing

  • Investigational Site Number 156011

    Chongqing

  • Investigational Site Number 156009

    Dalian

  • Investigational Site Number 156008

    Guangzhou

  • Investigational Site Number 156012

    Haikou

  • Investigational Site Number 156007

    Nanjing

  • Investigational Site Number 156001

    Shanghai

  • Investigational Site Number 156002

    Shanghai

  • Investigational Site Number 156003

    Shanghai

  • Investigational Site Number 156010

    Shenyang

Other trials in China

Greece10 sites

  • Investigational Site Number 300006

    Alexandroupoli, 68100

  • Investigational Site Number 300001

    Athens

  • Investigational Site Number 300002

    Athens

  • Investigational Site Number 300003

    Athens

  • Investigational Site Number 300004

    Athens

  • Investigational Site Number 300005

    Irakleio, 71001

  • Investigational Site Number 300011

    Maroussi, Athens, 15123

  • Investigational Site Number 300008

    Thessaloniki, 546 36

  • Investigational Site Number 300010

    Thessaloniki, 56429

  • Investigational Site Number 300007

    Thessaloniki, 57010

Other trials in Greece

Italy10 sites

  • Investigational Site Number 380-010

    Catania, 95122

  • Investigational Site Number 380-008

    Catania, 95124

  • Investigational Site Number 380-006

    Colleferro, 00034

  • Investigational Site Number 380-007

    Foggia, 71100

  • Investigational Site Number 380-005

    Forlì

  • Investigational Site Number 380-001

    Genova, 16132

  • Investigational Site Number 380-011

    Merano, 39100

  • Investigational Site Number 380-009

    Naples, 80131

  • Investigational Site Number 380-012

    Naples, 80131

  • Investigational Site Number 380-004

    Parma, 43100

Other trials in Italy

Spain9 sites

  • Investigational Site Number 724001

    Ávila, 05071

  • Investigational Site Number 724002

    Barcelona, 08022

  • Investigational Site Number 724008

    Galdakao, 48960

  • Investigational Site Number 724007

    Lugo, 27004

  • Investigational Site Number 724004

    Madrid, 28805

  • Investigational Site Number 724009

    Pamplona, 31008

  • Investigational Site Number 724005

    Santa Coloma de Gramanet, 8923

  • Investigational Site Number 724003

    Seville, 41010

  • Investigational Site Number 724006

    Valencia, 46010

Other trials in Spain

Turkey (Türkiye)9 sites

  • Investigational Site Number 792-013

    Ankara, 06100

  • Investigational Site Number 792-009

    Çanakkale, 17110

  • Investigational Site Number 792-006

    Diyarbakır, 21830

  • Investigational Site Number 792-004

    Istanbul, 34098

  • Investigational Site Number 792-001

    Izmir, 35340

  • Investigational Site Number 792-016

    Konya

  • Investigational Site Number 792-007

    Sivas, 58140

  • Investigational Site Number 792-005

    Trabzon

  • Investigational Site Number 792-002

    Van, 65080

Other trials in Turkey (Türkiye)

Taiwan8 sites

  • Investigational Site Number 158004

    Changhua County

  • Investigational Site Number 158007

    Kaohsiung Hsien,

  • Investigational Site Number 158006

    New Taipei City

  • Investigational Site Number 158001

    Taichung, 407

  • Investigational Site Number 158009

    Taichung

  • Investigational Site Number 158005

    Tainan

  • Investigational Site Number 158002

    Taipei

  • Investigational Site Number 158003

    Xindian District, 23137

Other trials in Taiwan

India7 sites

  • Investigational Site Number 356008

    Bangalore, 560043

  • Investigational Site Number 356003

    Bangalore, 560052

  • Investigational Site Number 356007

    Bangalore, 560092

  • Investigational Site Number 356006

    Bhubaneswar, 751019

  • Investigational Site Number 356001

    Hyderabad, 500034

  • Investigational Site Number 356005

    Hyderabad, 500034

  • Investigational Site Number 356004

    Trivandrum

Other trials in India

Brazil5 sites

  • Investigational Site Number 076002

    Belém, 66073-000

  • Investigational Site Number 076005

    Curitiba, 80060-900

  • Investigational Site Number 076004

    Fortaleza, 60430-370

  • Investigational Site Number 076001

    Porto Alegre, 90035-001

  • Investigational Site Number 076003

    São Paulo, 04024-002

Other trials in Brazil

Colombia5 sites

  • Investigational Site Number 170001

    Bogotá

  • Investigational Site Number 170002

    Bogotá

  • Investigational Site Number 170003

    Bucaramanga

  • Investigational Site Number 170005

    Manizales, 170

  • Investigational Site Number 170004

    Pereira, 170

Other trials in Colombia

Mexico5 sites

  • Investigational Site Number 484004

    Aguascalientes, 20020

  • Investigational Site Number 484001

    Aguascalientes, 20230

  • Investigational Site Number 484003

    Guadalajara, 44650

  • Investigational Site Number 484002

    Guadalajara, 44680

  • Investigational Site Number 484005

    Puebla City, 72000

Other trials in Mexico

Austria4 sites

  • Investigational Site Number 040-004

    Sankt Stefan, A-8511

  • Investigational Site Number 040-002

    Vienna, A-1030

  • Investigational Site Number 040-001

    Vienna

  • Investigational Site Number 040-003

    Vienna

Other trials in Austria

South Korea4 sites

  • Investigational Site Number 410004

    Ansan-si, Kyouggi-do

  • Investigational Site Number 410003

    Koyang-si

  • Investigational Site Number 410001

    Seoul

  • Investigational Site Number 410002

    Seoul

Other trials in South Korea

Denmark3 sites

  • Investigational Site Number 208-001

    Hvidovre, 2650

  • Investigational Site Number 208-003

    København NV, 2400

  • Investigational Site Number 208-002

    København S, 2300

Other trials in Denmark

Romania3 sites

  • Investigational Site Number 642001

    Iași, 700111

  • Investigational Site Number 642002

    Iași

  • Investigational Site Number 642003

    Oradea, 410169

Other trials in Romania

Kuwait1 site

  • Investigational Site Number 001

    Kuwait City

Other trials in Kuwait

United Arab Emirates1 site

  • Investigational Site Number 784-001

    Dubai

Other trials in United Arab Emirates

About this study

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

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.

Read more

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
Being tested
INSULIN GLARGINE, INSULIN GLULISINE, PREMIXED INSULIN
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

    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 GLULISINEDrug

    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 INSULINDrug

    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
Study groups in NCT01121835
Study groupRoleWhat they receive
Insulin glargineExperimentalAdministered once a day in the evening, at the same time every day. The starting daily dose is 0.2 U/Kg of body weight or 12 U, at the investigator's decision. Insulin glulisine is administered for patients of the insulin glargine group requiring insulin glulisine at week 12 (visit 11). Insulin glulisine is administered prior (10-15 min) to the main meal of the day, which is the meal with highest Post-Prandial Plasma Glucose (PPPG) on the 3 profiles performed before week 12. Starting dose is of 4 units per day.
Receives: Drug: INSULIN GLARGINE; Drug: INSULIN GLULISINE
Premixed insulinExperimentaladministered once a day (in the evening at dinner) or twice a day (in the morning before breakfast and in the evening at dinner). Starting daily dose will be 6 U at breakfast and 6 U at dinner, if administered twice a day or 12 U at dinner if administered once a day
Receives: Drug: PREMIXED INSULIN

What is being measured

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

  1. 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]

    Measured: From baseline (visit 2, week 0) to visit 14 (week 24)

Secondary outcomes (7)

  1. 7-point plasma glucose (PG) profile recorded on 3 consecutive days

    Measured: From baseline (visit 2, week 0) to visit 14 (week 24)

  2. Self-monitored PG (Plasma Glucose) values over 3 consecutive days

    Measured: before visit 4 (week 2)

  3. Self-monitored PG (Plasma Glucose) values over 3 consecutive days

    Measured: before visit 8 (week 6)

  4. Self-monitored PG (Plasma Glucose) values over 3 consecutive days

    Measured: before visit 12 (week 16)

  5. Weight and supine blood pressure

    Measured: From baseline (visit 2, week 0) to visit 14 (week 24)

  6. Insulin doses of the day before each visit

    Measured: from visit 3 (week 1) to visit 14 (week 24)

  7. Biochemistry and lipid profile

    Measured: From baseline (visit 2, week 0) to visit 14 (week 24)

Timeline

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

  1. First posted12 May 2010 (estimated)
  2. Study startFeb 2010
  3. Primary completionMar 2012
  4. Study completionMar 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
934 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01121835
Sponsor's protocol ID
LANTU_C_04589
Other IDs
2009-018172-33, U1111-1116-9859, 2009
Acronym
GALAPAGOS
Status last verified
Apr 2013
First submitted
6 May 2010
Last updated
4 Apr 2013
Results posted
No

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in