Study Assessing the Behavior of Delayed-Release Metformin in Subjects With Kidney Dysfunction

Inclusion Criteria:

1. Is 18 to 80 (inclusive) years old at Visit 1 (Screening).

2. Is male, or is female and meets all of the following criteria:

- Not breastfeeding

- Negative pregnancy test result (human chorionic gonadotropin, beta subunit) at
Visit 1 (Screening) (not applicable to hysterectomized females)

- Surgically sterile, postmenopausal, or if of childbearing potential, must
practice and be willing to continue to practice appropriate birth control during
the entire duration of the study

- Has body weight of ≥ 45 kg

3. Has a BMI of 18.0 to 40.0 kg/m2 (inclusive) at Visit 1 (Screening).

4. Has type 2 diabetes mellitus and an HbA1c ≤10.0%.

5. Has a physical examination with no clinically significant abnormalities as judged by
the investigator.

6. Has eGFR ≥15 mL/min/1.73 m2 based on the MDRD equation.

7. Ability to understand and willingness to adhere to protocol requirements

Exclusion Criteria:

1. Has End Stage Renal Disease requiring dialysis or severe renal dysfunction with eGFR
<15 mL/min/1.73 m2.

2. Is currently on dialysis or has been on dialysis within 12 months of Visit 1
(Screening).

3. Has received or plans to receive any iodinated contrast dye within 1 week prior to
Visit 1 (Screening) or after study medication administration.

4. Is currently taking or has taken within 1 week of Visit 1 cationic drugs that are
eliminated by renal tubular secretion (e.g., amiloride, digoxin, morphine,
procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim, and
vancomycin).

5. Has a clinically significant medical condition that could potentially affect study
participation and/or personal well-being, as judged by the investigator, including
but not limited to the following conditions:

- Hepatic disease

- Gastrointestinal disease

- Endocrine disorder (type 2 diabetes mellitus is allowed)

- Cardiovascular disease

- Central nervous system diseases

- Psychiatric or neurological disorders

- Organ transplantation

- Chronic or acute infection

- Orthostatic hypotension, fainting spells or blackouts

- Allergy or hypersensitivity

6. Has any chronic disease requiring medication that has been adjusted in the past 14
days(subjects may take acute intermittent over-the-counter medications such as
Tylenol, if needed).

7. Has had major surgery of any kind within 6 months of Visit 1 (Screening).

8. Has a clinically significant finding of an electrocardiogram (ECG) as assessed by the
investigator at Visit 1 (Screening).

9. Has clinical laboratory test (clinical chemistry, hematology, or urinalysis)
abnormalities, other than those related to diabetes or renal disease and other stable
diseases, judged by the investigator to be clinically significant at Visit 1
(Screening).

10. Has a hemoglobin result <8 g/dL or a level indicating severe anemia of renal origin.

11. Has physical, psychological, or historical finding that, in the investigator's
opinion, would make the subject unsuitable for the study.

12. Has received Byetta® or short-acting insulin within 3 days of Visit 1 (Screening).

13. Has received metformin within 4 weeks of Visit 1 (Screening).

14. Has any drug treatment that affects gastric pH (prescription or over-the-counter),
including any antacids or medications such as Rolaids or Pepcid within 2 days of
Visit 2.

15. Currently abuses drugs or alcohol or has a history of abuse that in the
investigator's opinion would cause the individual to be noncompliant with study
procedures.

16. Smokes more than 10 cigarettes, 3 cigars, or 3 pipes per day.

17. Has donated blood within 2 months of Visit 1 (Screening) or is planning to donate
blood during the study.

18. Has received any investigational drug within one month (or seven half-lives of the
investigational drug, whichever is greater) of Visit 1 (Screening).

19. Has known allergies or hypersensitivity to any component of study treatment.

20. Is employed by Elcelyx Therapeutics, Inc (that is an employee, temporary contract
worker, or designee of the company).