anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Bimatoprost
Trial phase: Phase 4
ATC code: S01EE03
SMILES: CCNC(=O)CCC/C=C\C[C@@H]1[C@@H](/C=C/[C@@H](O)CCc2ccccc2)[C@H](O)C[C@@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 35
Group description: bimatoprost 0.03%
Eligibility criteria:
Inclusion Criteria:

Diagnosis of open-angle glaucoma (pseudoexfoliative or pigmentary glaucomas are allowed) or ocular hypertension

Exclusion Criteria:

Known contraindication to latanoprost, bimatoprost or travoprost
Uncontrolled systemic disease
Active ocular disease other than glaucoma or ocular hypertension
Pregnant or lactating women or women of childbearing potential NOT utilizing a medically acceptable form of birth control
Intervention: Arixtra
Trial phase: Phase 3
SMILES: COC1OC(COS(=O)(=O)[O-])C(OC2OC(C(=O)O)C(OC3OC(COS(=O)(=O)[O-])C(OC4OC(C(=O)O)C(OC5OC(COS(=O)(=O)[O-])C(O)C(O)C5NS(=O)(=O)[O-])C(O)C4O)C(OS(=O)(=O)[O-])C3NS(=O)(=O)[O-])C(O)C2OS(=O)(=O)[O-])C(O)C1NS(=O)(=O)[O-].[Na+].[Na+].[Na+].[Na+].[Na+].[Na+].[Na+].[Na+].[Na+].[Na+]
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 3
Group description: Patients randomized to treatment arm will initiate ARIXTRA treatment on post-operative day 1 and continue treatment until post-operative day 22 (21 consecutive days). Subjects randomized to this arm are to receive the standard prophylactic dose for major abdominal surgery of 2.5mg/day for a total of 21 consecutive days (this includes both while in the hospital and after hospital discharge)
Eligibility criteria:
Inclusion Criteria:

All patients undergoing open laparotomy (non-laparoscopic) gynecologic surgery.
Patients must be competent to self-administer injections, or must have caregivers or nurses who can perform injections
Patients must have signed an approved informed consent

Exclusion Criteria:

Patients with medical history which requires chronic anticoagulation (i.e. previous DVT, pulmonary embolism, atrial fibrillation, heart valve replacement)
Patients with contraindications to anticoagulation (generalized bleeding disorders, peptic ulcer disease, hemorrhagic stroke, etc)
Contraindications to placement of ICDs (history of lower extremity venous stasis ulcers)
Patients receiving low molecular weight heparin or unfractionated heparin for prophylaxis post-operatively
Patients who are unable to receive injections as an outpatient and/or unable to undergo a doppler ultrasound of the lower extremities
Renal insufficiency (creatinine clearance < 30 mL/min)
Patients who have a body weight < 50 kg
Hypersensitivity to low molecular weight heparin
Patients who are pregnant or have a positive pregnancy test.
Patients receiving continuous (indwelling) epidural.
Intervention: Tamsulosin
Trial phase: Phase 2
ATC code: G01AE10 | G04CA02 | G04CA52 | G04CA53 | G04CA54
SMILES: CCOc1ccccc1OCCN[C@H](C)Cc1ccc(OC)c(S(N)(=O)=O)c1
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 49
Group description: 0.2 mg by mouth once a day
Eligibility criteria:
Inclusion Criteria:

Have Benign Prostatic Hyperplasia - Lower Urinary Tract Symptoms (BPH-LUTS) for at least 6 months prior to Visit 1.
Agree not to use any other approved or experimental treatments for erectile dysfunction or BPH-LUTS during the study.
Have not taken Finasteride therapy for at least 3 months prior to Visit 2.
Have not taken Dutasteride therapy for at least 6 months prior to Visit 2.
Have an International Prostate Symptom Score (IPSS) total score greater than or equal to 13 at Visit 2.

Exclusion Criteria:

Prostate Specific Antigen (PSA) greater than 10.0 nanograms per milliliter (ng/mL) at Visit 1.
Bladder Post Void Residual (PVR) greater than or equal to 300 mL by ultrasound at Visit 1.
History of pelvic surgery, prostatectomy, radiotherapy, penile implant surgery, lower urinary tract malignancy or trauma.
Urinary tract infection or inflammation or current antibiotic therapy for urinary tract infection at Visit 1.
Glycosylated hemoglobin (HbA1c) greater than 9% at Visit 1.
Intervention: Atorvastatin
Trial phase: Phase 4
ATC code: C10AA05 | C10BA05 | C10BX03 | C10BX06 | C10BX08 | C10BX11 | C10BX12 | C10BX15 | C10BX18 | C10BX19
SMILES: CC(C)c1c(C(=O)Nc2ccccc2)c(-c2ccccc2)c(-c2ccc(F)cc2)n1CC[C@@H](O)C[C@@H](O)CC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 425
Group description: this patient group consists of dyslipidemia patients with various cardiovascular diseases (CVD)risk factors
Eligibility criteria:
Inclusion Criteria:

Is a Korean , dyslipidemic outpatient
Is eligible for LDL-lowering drug therapy at screening and baseline as determined by the following LDL-cholesterol (LDL-C) cut-off points defined by NCEP ATP Ⅲ: 2. 1 LDL-C ≥ 190 mg/dL for subjects with 0 or 1 CHD risk factor 2. 2 LDL-C ≥ 160 mg/dL for subjects with 2 or more CHD risk factors and 10 year risk < 10 % 2. 3 LDL-C ≥ 130 mg/dL for subjects with 2 or more CHD risk factors and 10 year risk 10-20 % 2. 4 LDL-C ≥ 100 mg/dL for subjects with documented CHD or CHD risk equivalents (10-year risk > 20 %)
Has LDL-C ≤ 220mg/dL at baseline 4. Has triglyceride level ≤ 600mg/dL at baseline

Exclusion Criteria:

Is pregnant or lactating
Has present myopathy or history of myopathy or has personal or familial history of hereditary muscular disorders or any history of rhabdomyolysis
Has history of intolerance or hypersensitivity to atorvastatin or other statins
Uncontrolled hypertension (i.e. moderate hypertension, sitting systolic BP ≥ 160mmHg and/or diastolic BP ≥ 100mmHg)
Has HbAlc > 10%
Has any severe disease of has had any major problem or surgical procedure within the 3 months prior to screening that is likely to jeopardize the planned termination of the study. (e.g., any carcinoma, coronary angioplasty, coronary artery bypass graft, cardiac infarct, severe or unstable angina pectoris)
Intervention: Rilpivirine
Trial phase: Phase 3
ATC code: J05AG05 | J05AR08 | J05AR19 | J05AR21
SMILES: Cc1cc(/C=C/C#N)cc(C)c1Nc1ccnc(Nc2ccc(C#N)cc2)n1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 346
Group description: 25 milligram (mg) tablet once daily for 96 weeks.
Eligibility criteria:
Inclusion Criteria:

Patient with documented HIV-1 infection
Patient has never been treated with a therapeutic HIV vaccine or an ARV drug prior to screening
Patient's HIV-1 plasma viral load at screening is > 5,000 HIV-1 RNA copies/mL (assayed by RNA PCR standard specimen procedure)
Patient's virus is sensitive to TDF and FTC
Patient agrees not to start ART (antiretroviral treatment) before the baseline visit

Exclusion Criteria:

Previous use of ANY ARV drug for ANY length of time
Any documented evidence of NNRTI resistance associated mutations in patient's HIV
Category C AIDS defining illness, except: stable Kaposi Sarcoma, wasting syndrome if not progressive
Pneumocystis carinii pneumonia (PCP) that is considered not cured
Active TB
Allergy or hypersensitivity to study or background ARTs
Specific grade 3 or 4 toxicity
Kidney impairment: calculated creatinine clearance <50 ml/min
Intervention: Sitagliptin Phosphate
Trial phase: Phase 1
SMILES: NC(CC(=O)N1CCn2c(nnc2C(F)(F)F)C1)Cc1cc(F)c(F)cc1F.O=P(O)(O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 78
Group description: Sitagliptin 200 mg Group included data from all randomized patients in treatment periods with once-daily administration of sitagliptin 200 mg. Due to the crossover design, patients are counted in the denominator for each treatment that they received. Patients are counted in the numerator for the treatment that they were receiving at the time when the AE occurred.
Eligibility criteria:
Inclusion Criteria:

Patient has Type 2 Diabetes
Patient is between the ages of 30-65 years
Patient is not on an antihyperglycemic agent (AHA) (glycosylated hemoglobin [A1C] 7-10% ), or is on oral single AHA or low-dose combination therapy (A1C 6.5-9.5%).

Exclusion Criteria:

Patient has Type 1 Diabetes
Patient has been treated with sitagliptin, vildagliptin, or other similar drugs or has been treated with exenatide in the past 3 months
Patient has taken insulin within the past 3 months
Intervention: Sitagliptin Phosphate
Trial phase: Phase 1
SMILES: NC(CC(=O)N1CCn2c(nnc2C(F)(F)F)C1)Cc1cc(F)c(F)cc1F.O=P(O)(O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 72
Group description: Sitagliptin 100 mg Group included data from all randomized patients in treatment periods with once-daily administration of sitagliptin 100 mg. Due to the crossover design, patients are counted in the denominator for each treatment that they received. Patients are counted in the numerator for the treatment that they were receiving at the time when the AE occurred.
Eligibility criteria:
Inclusion Criteria:

Patient has Type 2 Diabetes
Patient is between the ages of 30-65 years
Patient is not on an antihyperglycemic agent (AHA) (glycosylated hemoglobin [A1C] 7-10% ), or is on oral single AHA or low-dose combination therapy (A1C 6.5-9.5%).

Exclusion Criteria:

Patient has Type 1 Diabetes
Patient has been treated with sitagliptin, vildagliptin, or other similar drugs or has been treated with exenatide in the past 3 months
Patient has taken insulin within the past 3 months
Intervention: RISEDRONIC ACID
Trial phase: Phase 3
ATC code: M05BA07 | M05BB02 | M05BB04 | M05BB07
SMILES: O=P(O)(O)C(O)(Cc1cccnc1)P(=O)(O)O
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 307
Group description: 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
Eligibility criteria:
Inclusion Criteria:

Female: 50 years of age or older
>5 years since last menses natural or surgical
have lumbar spine or total hip BMD more that 2.5 SD below the young adult mean, or have lumbar spine or total hip BMD more than 2.0 SD below the young adult female mean value and also have at least one prevalent vertebral body fracture

Exclusion Criteria:

history of uncontrolled hyperparathyroidism, hyperthyroidism, osteomalacia
BMI >32 kg/m
use of medications within 3 months of starting study drug that impact bone metabolism such as glucocorticoids, estrogens, calcitonin, calcitriol, other bisphosphonates and parathyroid hormone
hypocalcemia or hypercalcemia of any cause
markedly abnormal clinical laboratory measurements that are assessed as clinically significant by the investigator
Intervention: Acetylcysteine
Trial phase: Phase 1 | Phase 2
ATC code: R05CB01 | S01XA08 | V03AB23
SMILES: CC(=O)N[C@@H](CS)C(=O)O
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 24
Group description: All participants received N-Acetylcysteine 1200 mg twice daily during four weeks of participation. Tolerability, marijuana use, and reactivity to marijuana cues were investigated.
Eligibility criteria:
Inclusion Criteria:

Male or female, 12 - 20 years old.
Participants must be regular smokers of marijuana (on average smoke at least 3 times per week for at least one year) and meet DSM-IV Criteria for cannabis dependence, with desire to cut down on marijuana use.
Participants must understand all oral and written informed consent and give such consent prior to on-site screening.
Participants must agree to refrain from marijuana use for 24 hours prior to each cue reactivity session (Visits 2 and 4).
Participants must have a person that can be contacted in case of emergency.
Participants must have had stable residence for the past 30 days.
Post-menarchal female participants must agree to use birth control to avoid pregnancy.

Exclusion Criteria:

Allergy or intolerance to N-Acetylcysteine (NAC).
Pregnancy or lactation.
History of seizures.
Current or past history of asthma and/or the occasional or daily use of albuterol or other beta-agonist inhalers.
Current use of medications that might affect heart rate or skin conductance.
Use of carbamazepine or nitroglycerin (or any other medication deemed to be hazardous if taken with NAC) within 14 days of study.
History of significant hepatic, renal, endocrine, cardiac (i.e., arrhythmia requiring medication, angina pectoris, myocardial infarction,), stroke, seizure, neurological, psychiatric, gastrointestinal, pulmonary, hematologic, metabolic, or other disorders that may place the participant at increased risk per the judgment of the study physician.
Intervention: Omeprazole
Trial phase: Phase 3
ATC code: A02BC01 | A02BC05 | A02BD01 | A02BD05 | A02BD06 | A02BD16 | M01AE52
SMILES: COc1ccc2nc(S(=O)Cc3ncc(C)c(OC)c3C)[nH]c2c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 173
Group description: Esomeprazole 20 mg once daily oral
Eligibility criteria:
Inclusion Criteria:

Medical history of gastric and/or duodenal ulcer
A diagnosis of a chronic condition (rheumatoid arthritis, osteoarthritis, lumbago,etc) that requires daily NSAID use,at least 20 years of age

Exclusion Criteria:

Having gastric or duodenal ulcer in active or healing stage according to the Sakita/Miwa classification
History of esophageal, gastric or duodenal surgery
Having severe liver disease or chronic renal disease
Intervention: Nesiritide
Trial phase: Phase 2
ATC code: C01DX19
SMILES: CCC(C)C1NC(=O)C(CCCNC(=N)N)NC(=O)C(CC(=O)O)NC(=O)C(CCSC)NC(=O)C(CCCCN)NC(=O)C(CCCNC(=N)N)NC(=O)CNC(=O)C(Cc2ccccc2)NC(=O)C(NC(=O)CNC(=O)C(CO)NC(=O)CNC(=O)C(CCC(N)=O)NC(=O)C(NC(=O)C(CCSC)NC(=O)C(CCCCN)NC(=O)C2CCCN2C(=O)C(N)CO)C(C)C)CSSCC(C(=O)NC(CCCCN)C(=O)NC(C(=O)NC(CC(C)C)C(=O)NC(CCCNC(=N)N)C(=O)NC(CCCNC(=N)N)C(=O)NC(Cc2c[nH]cn2)C(=O)O)C(C)C)NC(=O)CNC(=O)C(CC(C)C)NC(=O)CNC(=O)C(CO)NC(=O)C(CO)NC(=O)C(CO)NC(=O)C(CO)NC1=O
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 35
Group description: Patients assigned to the nesiritide group will receive an intravenous loading dose of 2 mcg/kg followed by an infusion of 0.015 mcg/kg/min, administered for at least 12 hours after CICU admission and up to five days unless prespecified lack of efficacy criteria are met.

nesiritide: Nesiritide bolus 2 mcg/kg on CPB, then infusion of 0.015 mcg/kg/min. infusion dose may be adjusted
Eligibility criteria:
Inclusion Criteria:

Patients undergoing an elective, primary Fontan operation at Children's Hospital Boston.

Exclusion Criteria:

Revision surgery for failing Fontan circulation.
Preoperative serum creatinine > 1.5 mg/dL or chronic dialysis.
The attending surgeon, cardiac anesthesiologist, or cardiac intensivist has a compelling indication to initiate either nesiritide or milrinone outside of the confines of the study.
Intervention: MK-5108
Trial phase: Phase 1
SMILES: O=C(O)[C@]1(Cc2cccc(Nc3nccs3)n2)CC[C@@H](Oc2cccc(Cl)c2F)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 3
Group description: Participants received 400 mg of MK-5108 orally BID the first 2 days of a 14-day cycle (cycle extended to 21 days if ≥Grade 2 toxicity observed).
Eligibility criteria:
Inclusion Criteria:

- Participant has a histologically-confirmed metastatic or locally advanced solid tumor that has failed to respond to standard therapy or progressed with standard therapy

Exclusion Criteria:

Participant has had chemotherapy, radiotherapy or biological therapy within 4 weeks prior to study start or has not recovered from adverse events caused by therapy more than 4 weeks earlier
Participant is currently participating or has participated in a study with an investigational compound or device within 4 weeks prior to signing informed consent
Participant has received more than 2 courses of chemotherapy for metastatic disease
Participant has had prolonged neutropenia or neutropenia with fever from previous chemotherapy treatment
Participant has a primary central nervous system tumor
Participant is a regular or recreational user of any illicit drugs or has a recent history within the last year of drug or alcohol abuse
Participant is pregnant, breastfeeding or planning to have children during the study
Participant is Human Immunodeficiency Virus (HIV) positive
Participant has a history of Hepatitis B or C
Intervention: Donepezil Hydrochloride
Trial phase: Phase 2
SMILES: COc1cc2c(cc1OC)C(=O)C(CC1CCN(Cc3ccccc3)CC1)C2.Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 35
Group description: E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.

Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast.
Eligibility criteria:
Inclusion criteria:

Patients diagnosed as probable Dementia With Lewy Bodies (DLB) according to the diagnostic criteria for DLB.

Participants having caregivers who submit written consent for cooperative involvement in this study, can routinely stay with participants 3 days a week (at least 4 hours a day), provide participants' information necessary for this study, assist treatment compliance, and escort participants on required visits to study institution.

Exclusion criteria:

Participants with past experience of donepezil (Aricept) therapy at the same study institution.

Participants treated with donepezil in 3 months immediately before starting the observation period.

Participants with a complication of serious neuropsychiatric disease(s) such as stroke, brain tumor, schizophrenia, epilepsia, normal pressure hydrocephalus, mental retardation, brain trauma with unconsciousness, and/or experience of brain surgery causing unsolved deficiency.

Participants with severe complication of cardiovascular, hepatic, renal, hematological, or other diseases unable to secure the safety.

Pregnant or lactating women, or women who are willing to become pregnant no later than 1 month after the scheduled study completion

Participants with severe extrapyramidal disorders (Hoehn & Yahr staging score is ≥IV)

Participants whose systolic blood pressure is <90 mmHg or pulse rate is <50 beats/min.

Participants suspected to have a complication of vascular dementia based upon neurological findings.
Intervention: Donepezil Hydrochloride
Trial phase: Phase 2
SMILES: COc1cc2c(cc1OC)C(=O)C(CC1CCN(Cc3ccccc3)CC1)C2.Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 33
Group description: E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.

Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).

Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 84 (10 weeks).
Eligibility criteria:
Inclusion criteria:

Patients diagnosed as probable Dementia With Lewy Bodies (DLB) according to the diagnostic criteria for DLB.

Participants having caregivers who submit written consent for cooperative involvement in this study, can routinely stay with participants 3 days a week (at least 4 hours a day), provide participants' information necessary for this study, assist treatment compliance, and escort participants on required visits to study institution.

Exclusion criteria:

Participants with past experience of donepezil (Aricept) therapy at the same study institution.

Participants treated with donepezil in 3 months immediately before starting the observation period.

Participants with a complication of serious neuropsychiatric disease(s) such as stroke, brain tumor, schizophrenia, epilepsia, normal pressure hydrocephalus, mental retardation, brain trauma with unconsciousness, and/or experience of brain surgery causing unsolved deficiency.

Participants with severe complication of cardiovascular, hepatic, renal, hematological, or other diseases unable to secure the safety.

Pregnant or lactating women, or women who are willing to become pregnant no later than 1 month after the scheduled study completion

Participants with severe extrapyramidal disorders (Hoehn & Yahr staging score is ≥IV)

Participants whose systolic blood pressure is <90 mmHg or pulse rate is <50 beats/min.

Participants suspected to have a complication of vascular dementia based upon neurological findings.
Intervention: Donepezil Hydrochloride
Trial phase: Phase 2
SMILES: COc1cc2c(cc1OC)C(=O)C(CC1CCN(Cc3ccccc3)CC1)C2.Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 37
Group description: E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.

Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).

Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 42 (4 weeks).

Followed by two 5 mg Donepezil hydrochloride tablets (10 mg) by mouth, once daily after breakfast for Day 43- Day 84 (6 weeks).
Eligibility criteria:
Inclusion criteria:

Patients diagnosed as probable Dementia With Lewy Bodies (DLB) according to the diagnostic criteria for DLB.

Participants having caregivers who submit written consent for cooperative involvement in this study, can routinely stay with participants 3 days a week (at least 4 hours a day), provide participants' information necessary for this study, assist treatment compliance, and escort participants on required visits to study institution.

Exclusion criteria:

Participants with past experience of donepezil (Aricept) therapy at the same study institution.

Participants treated with donepezil in 3 months immediately before starting the observation period.

Participants with a complication of serious neuropsychiatric disease(s) such as stroke, brain tumor, schizophrenia, epilepsia, normal pressure hydrocephalus, mental retardation, brain trauma with unconsciousness, and/or experience of brain surgery causing unsolved deficiency.

Participants with severe complication of cardiovascular, hepatic, renal, hematological, or other diseases unable to secure the safety.

Pregnant or lactating women, or women who are willing to become pregnant no later than 1 month after the scheduled study completion

Participants with severe extrapyramidal disorders (Hoehn & Yahr staging score is ≥IV)

Participants whose systolic blood pressure is <90 mmHg or pulse rate is <50 beats/min.

Participants suspected to have a complication of vascular dementia based upon neurological findings.
Intervention: Sitagliptin Phosphate
Trial phase: Phase 3
SMILES: NC(CC(=O)N1CCn2c(nnc2C(F)(F)F)C1)Cc1cc(F)c(F)cc1F.O=P(O)(O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 412
Group description: Subjects received sitagliptin 100 mg once daily for 26 Weeks,

and:

No specific intervention (standard recommendation) on physical exercise and diet.
Eligibility criteria:
Inclusion Criteria:

Man or woman aged >/= 18 years,with T2DM and treated with the maximal tolerated dose of metformin, with documented or high likely inadequate control of diabetes (HbA1c 6.5-9%)

Exclusion Criteria:

Daily insulin treatment or one insulin dose or more within the last 8 weeks or expected insulin treatment within the next 3 months.
Hypoglycemia unawareness or recurrent major hypoglycemia or history of acidoketosis
Known hypersensitivity or contraindication to metformin