Long-term (52–78 weeks) treatment with colesevelam HCl added to metformin therapy in type 2 diabetes mellitus patients

Figures & data

Figure 1 Patient disposition.

Table 1 Demographic and baseline characteristics (safety population)

	Colesevelam (double-blind and open-label) (n = 196)	Placebo (double-blind)/colesevelam (open-label) (n = 166)
Age, years, mean (SD)	57.2 (9.1)	57.9 (9.0)
Sex, n (%)
Male	107 (54.6)	89 (53.6)
Female	89 (45.4)	77 (46.4)
Race, n (%)
Caucasian	126 (64.3)	107 (64.5)
Hispanic	44 (22.4)	36 (21.7)
Black	19 (9.7)	17 (10.2)
Asian	6 (3.1)	3 (1.8)
Other	1 (0.5)	3 (1.8)
Baseline A *
HbA1c, %, mean (SD)	8.2 (0.6)	8.2 (0.6)
FPG, mg/dL, mean (SD)	171 (43)	160 (41)
Baseline B **
HbA1c, %, mean (SD)	7.6 (0.9)	8.1 (0.9)
FPG, mg/dL, mean (SD)	156 (47)	173 (49)
Concomitant anti-diabetic medications at baseline B, n (%)
Metformin alone	50 (25.5)	35 (21.1)
Metformin + sulfonylurea	75 (38.3)	55 (33.1)
Metformin + thiazolidinedione	4 (2.0)	6 (3.6)
Metformin + sulfonylurea + thiazolidinedione	27 (13.8)	26 (15.7)
Metformin + insulin	15 (7.7)	18 (10.8)
Metformin + insulin + OADs†	25 (12.8)	26 (15.7)

Notes:

* Last measurement prior to first dose of study medication during the double-blind study;

** Last measurement obtained during the double-blind study prior to first dose of open-label colesevelam;

† Included one or more OADs in addition to metformin.

Abbreviations: FPG, fasting plasma glucose; HbA_1c, hemoglobin A_1c; OADs, oral anti-diabetes drugs; SD, standard deviation.

Table 2 Summary of adverse events (safety population)

	Colesevelam (double-blind and open-label) (n = 196)	Placebo (double-blind)/colesevelam (open-label) (n = 166)
Patients with AEs, n (%)
All AEs	132 (67.3)	119 (71.7)
Drug-related AEs	16 (8.2)	22 (13.3)
Severity of AEs, n (%)
Mild	67 (34.2)	51 (30.7)
Moderate	54 (27.6)	51 (30.7)
Severe	11 (5.6)	17 (10.2)
Deaths, n (%)	1 (0.5)	0 (0.0)
Patients with SAEs, n (%)
All SAEs	17 (8.7)	18 (10.8)
Drug-related SAEs	1 (0.5)	0 (0.0)
Patients withdrawn due to AEs, n (%)
Due to AEs	10 (5.1)	14 (8.4)
Due to drug-related AEs	4 (2.0)	6 (3.6)
Due to SAEs	4 (2.0)	4 (2.4)
AEs occurring in >2% of patients, n (%)
Anemia NOS	5 (2.6)	3 (1.8)
Arthralgia	5 (2.6)	8 (4.8)
Back pain	5 (2.6)	5 (3.0)
Bronchitis NOS	8 (4.1)	5 (3.0)
Chest pain	4 (2.0)	5 (3.0)
Constipation	2 (1.0)	5 (3.0)
Diarrhea NOS	1 (0.5)	5 (3.0)
Dizziness	6 (3.1)	1 (0.6)
Dyspepsia	6 (3.1)	3 (1.8)
Edema peripheral	7 (3.6)	7 (4.2)
Headache	7 (3.6)	4 (2.4)
Hypertension NOS	10 (5.1)	7 (4.2)
Hypoglycemia NOS	6 (3.1)	5 (3.0)
Nasopharyngitis	4 (2.0)	5 (3.0)
Nausea	2 (1.0)	6 (3.6)
Pneumonia NOS	5 (2.6)	1 (0.6)
Rash NOS	2 (1.0)	4 (2.4)
Sinusitis NOS	10 (5.1)	9 (5.4)
Upper respiratory tract infection NOS	13 (6.6)	13 (7.8)
Urinary tract infection NOS	17 (8.7)	12 (7.2)

Abbreviations: AE, adverse event; NOS, not otherwise specified; SAE, serious AE.

Figure 2 Mean (± standard error) change in hemoglobin A_1c(HbA_1c) with colesevelam (3.75 g/day) versus a placebo in the double-blind phase (starting at baseline A) when added to metformin-based treatment in patients with inadequately controlled type 2 diabetes mellitus (safety population). In the open-label extension phase (starting at baseline B), all study participants received colesevelam (3.75 g/day).

Figure 3 Mean (± standard error) change in fasting plasma glucose with colesevelam (3.75 g/day) versus the placebo in the double-blind phase (starting at baseline A) when added to metformin-based treatment in patients with inadequately controlled type 2 diabetes mellitus (safety population). In the open-label extension phase (starting at baseline B), all study participants received colesevelam (3.75 g/day).

Abbreviation: FPG, fasting plasma glucose.

Figure 4 Mean (± standard error)* change in lipids and apolipoproteins with colesevelam (3.75 g/day) in the double-blind phase (starting at baseline A) when added to metformin-based treatment in patients with inadequately controlled type 2 diabetes mellitus (safety population). In the open-label extension phase (starting at baseline B), all study participants received colesevelam (3.75 g/day).

Note: *Triglycerides are presented as median.
Abbreviations: Apo, apolipoprotein; HDL-C, high-density lipoprotein cholesterol; LDL-C, low density lipoprotein cholesterol.