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CompletedNCT01336751Updated Apr 18, 2011

Lantus Versus Humalog Mix as add-on Therapy in Type Diabetes Patients Failing Sulfonylurea and Metformin Combination Treatment

A Phase 3 interventional study of Insulin glargine and 75% insulin lispro protamine suspension and 25 % insulin lispro injection in Diabetes Mellitus, Type 2, sponsored by Sanofi. Completed at 1 site in United States. Open to participants aged 18 Years to 79 Years. Per ClinicalTrials.gov, last updated 2011-04-18.

Sponsored by Sanofi · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
212
Allocation
Randomized
Ages
18 Years to 79 Years
Sex
All
01

Study summary

Study Primary Objectives:

To compare glycemic control, as measured by hemoglobin A1c (A1C), between insulin glargine and 75% insulin lispro protamine suspension/25% insulin lispro as add-on therapies in subjects who failed oral combination therapy with sulfonylurea and metformin.

Study Secondary Objectives :

To compare the following measures between subjects receiving insulin glargine or 75% insulin lispro protamine suspension/25% insulin lispro:

  • Incidence of hypoglycemia
  • Change in weight
  • Change in serum lipid profile
  • Percentage of subjects achieving A1C levels ≤7%
Read the detailed description

The planned duration of enrollment is 6 months. The study consists of 2 weeks screening phase and a study period that was planned to be 24 weeks.

02

Conditions studied

  • Diabetes Mellitus, Type 2
03

In context

Diabetes Mellitus, Type 2

9,589 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,332 are open to participants now.

This study's enrollment of 212 is above the median of 81 across 7,713 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Sanofi is the lead sponsor of 1,547 studies on the registry; 88 are open to participants now.

Of its 204 completed or terminated interventional studies of FDA-regulated products, 122 (60%) have results posted.

Browse Sanofi studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 79 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients must have given their signed informed consent.
  • Males or females between 18 and 79 years of age.
  • Diagnosis of type 2 diabetes mellitus for at least one year.
  • Patients must have had continuous oral hypoglycemic treatment for at least three months using dosing of: at least half maximally labeled dose of sulfonylurea + at least 1000 mg metformin daily.
  • HBA1C ≥ 8 % and ≤11 %, inclusive, as measured at screening (visit 1).
  • Patients must have BMI of > 25 kg/m2 at baseline
  • Willingness to accept, and demonstrate ability to inject insulin glargine or 75% insulin lispro protamine suspension and 25% insulin lispro injection therapy.
  • Ability and willingness to perform SMBG profiles using a plasma glucose meter at least twice a day.
  • Patients must be able to understand and willing to adhere to and be compliant with the study protocol

Exclusion criteria

Exclusion Criteria:

  • Patients, who have had stroke, MI, coronary artery bypass graft (CABG), percutaneous transluminal coronary angioplasty (PTCA) or angina pectoris within the last 12 months.
  • Patients with congestive heart failure requiring pharmacological treatment.
  • Patients on non-selective beta blockers (including ocular).
  • Patients with impaired renal function, as shown by but not limited to serum creatinine ≥ 1.5 mg/dl (133μmol/L) for males, or ≥ 1.4 mg/dl (124 μmol/L) for females.
  • Patients with acute infections.
  • Patients with diagnosis of dementia.
  • Treatment with systemic steroids or large doses of inhaled steroids.
  • Patients with acute or chronic metabolic acidosis, including diabetic ketoacidosis.
  • Patients with planned radiological examinations requiring administration of contrasting agents.
  • Clinical evidence of active liver disease, or serum ALT 2.5 times the upper limit of the normal range.
  • Patients with history of hypoglycemia unawareness.
  • Pregnant or lactating females.
  • Failure to use adequate contraception (women of current reproductive potential only).

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

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
212 participants (actual)

Study arms

  • Experimental
    Insulin glargine

    Lantus (insulin glargine) administered subcutaneously 15 minutes before the evening meal for 24 weeks. The initial dosage was 10 units /day for 7 days. This was followed by titration every 7 days by increasing the dosage until control was established. Insulin dosages were increased according to a subject's glucose values determined by Self-monitoring blood glucose (SMBG). The starting dosage of metformin or sulfonylurea was the dosage the subject was taking when randomized. The dosage was to remain unchanged during the course of the study. The administration schedule was left to the discretion of the investigator.

    Drug: Insulin glargine

  • Active comparator
    Lispro mix

    Humalog Mix 75/25 (lispro mix) administered subcutaneously 15 minutes before the evening meal for 24 weeks. The initial dosage was 10 units /day for 7 days. This was followed by titration every 7 days by increasing the dosage until control was established. Insulin dosages were increased according to a subject's glucose values determined by self-monitoring blood glucose (SMBG). The starting dosage of metformin or sulfonylurea was the dosage the subject was taking when randomized. The dosage was to remain unchanged during the course of the study. The administration schedule was left to the discretion of the investigator.

    Drug: 75% insulin lispro protamine suspension and 25 % insulin lispro injection

Interventions

  • DrugInsulin glargine

    solution for subcutaneous injection

    Also known as: Lantus

  • Drug75% insulin lispro protamine suspension and 25 % insulin lispro injection

    Drug page: Insulin Lispro

    suspension for subcutaneous injection

    Also known as: Humalog

06

What researchers measure

Primary outcomes

  1. Change from baseline in hemoglobin A1c (HbA1c) levels at week 24

    Time frame: 24 weeks

Secondary outcomes

  1. Percentage of Patients Achieving Glycosylated Hemoglobin A1c (HbA1c) values ≤ 7.0% at Week 24

    Time frame: 24 weeks

  2. Percentage of Patients Achieving Glycosylated Hemoglobin A1c (HbA1c) values ≤ 8.0% at Week 24

    Time frame: 24 weeks

  3. Change from baseline in fasting plasma glucose (FBG) values at week 24

    Time frame: 24 weeks

  4. Change from baseline in serum lipid values at week 24

    Time frame: 24 weeks

  5. Number and severity of hypoglycemic events and time of occurrence of hypoglycemic events

    Time frame: 24 weeks

07

Study locations

1 site
  • Sanofi-Aventis Administrative Office
    Bridgewater, New Jersey, United States
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jul 2001, a primary completion of Dec 2002 and a completion of Dec 2002. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 14, 2011
First posted
Apr 18, 2011
Start
Jul 2001
Primary completionActual
Dec 2002
CompletionActual
Dec 2002
Last update
Apr 18, 2011
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 18, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01336751
Lead sponsor
Sanofi
First posted
Apr 18, 2011
Start date
Jul 2001
Primary completion
Dec 2002
Completion
Dec 2002
Last update
Apr 18, 2011

Study contacts

Medical Affairs
study director · Sanofi
View the source record on ClinicalTrials.gov ↗

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