All To Target Trial Lantus® (insulin glargine) with stepwise addition of APIDRA®(insulin
glulisine) or Lantus with one injection of Apidra vs. a twice-daily premixed insulin regimen
(Novolog® Mix 70/30) in adult subjects with type 2 diabetes failing dual or triple therapy
with oral agents: a 64-week, multi-center, randomized,parallel, open- label clinical study.
The following information on clinical trials is provided for information purposes only to
allow patients and physicians to have an initial discussion about the trial. This
information is not intended to be complete information about the trial, to contain all
considerations that may be relevant to potential participation in the trial, or to replace
the advice of a personal physician or health professional.
INCLUSION CRITERIA:
- Diagnosis of Type 2 Diabetes Mellitus for at least 2 years
- Male or Female subjects 30-80 years of age
- A1C >7. 5 % at screening, and A1c >7. 0% at randomization
- BMI <45 kg/m2
- On stable dual or triple oral therapy for at least 3 months (any combination of
secretagogue (sulfonylurea or repaglinide), metformin, and Actos (pioglitazone). The
oral agents must be in 2 or 3 of the following 3 different classes: a. Sulfonylurea or
repaglinide: dosage greater than or equal to one-half the maximum daily recommended
dosage; i. e., glimepiride > 4 mg; glipizide, including GITS >10 mg; glyburide > 10 mg;
Glynase® > 3 mg; or repaglinide (Prandin®) > 2 mg with each meal. The dosage must have
been stable for at least 3 months prior to screening. b. Biguanide: metformin dosage >
1000 mg daily including Glucophage XR®. The dosage must have been stable for at least
3 months prior to screening c. Thiazolidinedione: Actos pioglitazone) greater than or
= to 15 mg only. The subject must have been using Actos for at least 6 months, and the
dosage must have been stable for at least 3 months, prior to screening. Subjects using
Avandia (rosiglitazone) will not be allowed to enroll into the study.
- Ability and willing to perform SMBG up to four times a day, and at least 8 times daily
during the 8-point BG profile measurement days
- Able and willing to adhere to and be compliant with the study protocol
- Able to read English or Spanish at the sixth- grade level in order to complete the
subject reported outcomes component of the study
- Signed informed consent and study specific HIPAA documents
EXCLUSION CRITERIA:
- Subjects on any other anti-diabetic drug treatments other than the one required by the
protocol within the last 3 months before the study entry. Subjects discontinuing
Januvia due to nontolerance may be allowed in the study after a 2-week wash out
period.
- Clinically significant peripheral edema, if on a TZD
- Planned pregnancy, pregnant or lactating females
- History of hypoglycemia unawareness
- Acute or chronic or history of metabolic acidosis, including diabetic ketoacidosis
- Impaired renal function, as shown by but not limited to, serum creatinine greater than
or = to 3. 0 mg/dL. For subjects treated with metformin - serum creatinine greater than
or = to 1. 5 mg/dL (133 μmol/L) for males or greater than or = to 1. 4 mg/dL (124 μmoL)
for females
- Subjects receiving glucocorticoids, nonselective B-blockers, or weight-control agents
- Insulin use >1 week within prior year
- Acute infection
- Any clinically significant renal disease (other than proteinuria) or hepatic disease
- A serum SGPT level greater than 2. 5 X the upper limit of normal
- Any malignancy within the last 5 years, with the exception of adequately treated basal
or squamous cell carcinoma, or adequately treated cervical carcinoma in situ
- Diagnosis of dementia or mental condition rendering the subject unable to understand
the nature, scope, and possible consequences of the study
- Diagnosis of impaired dexterity or vision rendering the subject unable to administer
MDI injections
- History of or current congestive heart failure (cardiac status NYHA II-IV) requiring
pharmacological treatment; history of stroke, myocardial infarction coronary artery
bypass graft, percutaneous transluminal coronary angioplasty, or angina pectoris
within the last 12 months
- Known hypersensitivity to insulin glargine, insulin glulisine, NovoLog Mix® (70/30) or
any components of Lantus®, Apidra® or NovoLog Mix® (70/30).
- Any disease or condition (including abuse of illicit drugs, prescription medicines or
alcohol)within last 2 years, that in the opinion of the investigator or sponsor may
interfere with the completion of the study
- Unlikely to comply with protocol, e. g., uncooperative attitude, inability to return
for followup visits, and/or unlikely to complete the study
- Subject is the investigator or any sub-investigator, research assistant, pharmacist,
study coordinator, other staff, or relative thereof directly involved in the conduct
of the protocol
